Device manufacturer, as written on reports

Stryker Orthopaedics-Mahwah: medical device reports filed with FDA

42,446 reports name it as the manufacturer of the device involved, 2010–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

42,446
reports naming it as manufacturer: 0.2% of all MAUDE reports; 1,417
reports, 12 months to August 2026: 1,530 in the 12 months before; 16.6%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

42,446 medical device reports received by FDA give Stryker Orthopaedics-Mahwah as the manufacturer of the device involved, 0.2% of the MAUDE database, from January 2010 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

1,417 reports arrived in the 12 months to August 2026, close to the 1,530 of the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (83.2%), malfunction (16.6%) and death (0.2%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Unknown Reconstructive Product	Prosthesis, hip, semi-constrained, metal/polymer, cemented	2,561	0	0.4%
Triathlon Ps X3 Tibial Insert	Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer	925	21	0%
Triathlon Cr X3 Tibial Insert	Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer	564	13	0%
Trident 0 X3 Insert 36mm Id	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	551	0	0.2%
V40 Cocr Lfit Head 36mm/+5	Prosthesis, hip, semi-constrained, metal/polymer, cemented	497	0	0.2%
Unknown Knee	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	439	18	1.5%
Unknown Lfit Anatomic Cocr V40 Femoral Head	Prosthesis, hip, semi-constrained, metal/polymer, cemented	390	1	0%
Triathlon Prim Tib Baseplate - Cemented	Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer	292	3	0.5%
Trident Alumina Insert	Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented	265	0	0%
Trident 10 X3 Insert 36mm Id	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	262	0	0%
Unknown Cork Product	Prosthesis, hip, semi-constrained, metal/polymer, cemented	253	0	0%
Restoration Adm X3 Ins 28/48	Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate	241	6	0%
V40 Cocr Lfit Head 36mm/0	Prosthesis, hip, semi-constrained, metal/polymer, cemented	227	0	0%
Unknown Hip	Prosthesis, hip, semi-constrained, metal/polymer, cemented	217	5	1.9%
Accolade Plus Tmzf Hip Stem 4	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	216	6	0%
Triathlon Ps Fem Component Cemented	Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer	199	6	0.3%
Unknown Stryker Hip	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	195	36	0%
Accolade Plus Tmzf Hip Stem 3	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	190	5	0%
Modular Dual Mobility Insert	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented	178	6	0%
Unknown Accolade Tmzf Hip Stem	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	176	0	0%
Universal Driver Shaft	Orthopedic manual surgical instrument	175	0	0%
Unknown Stryker knee	Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer	172	17	0.5%
Exeter V40 Stem 44mm No 0	Prosthesis, hip, semi-constrained, metal/polymer, cemented	141	8	0%
Unknown Stem	Prosthesis, hip, semi-constrained, metal/polymer, cemented	136	84	0.5%
Simplex P-Japanese Twin Pack	Bone cement	111	1	10.6%
V40 Cocr Lfit Head 36mm/-5	Prosthesis, hip, semi-constrained, metal/polymer, cemented	102	0	0%
Unknown liner	Prosthesis, hip, semi-constrained, metal/polymer, cemented	95	75	0.4%
Tritanium Revision Acetabular	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	84	0	0.5%
Trident 10 X3 Insert 32mm Id	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	82	0	0%
Trident Hemispherical Cluster Hole Shell	Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate	77	0	0%

Brands with a page on this site, ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Device types

Product code	Device type	Reports	Share
LPH	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	10,180	24%
MBH	Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer	7,121	16.8%
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented	6,551	15.4%
JWH	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	5,401	12.7%
MEH	Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate	3,447	8.1%
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented	1,701	4%
LXH	Orthopedic manual surgical instrument	1,464	3.4%
KWA	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	907	2.1%
LOD	Bone cement	879	2.1%
KRO	Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer	868	2%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type

Death0.2%88

Injury83.2%35,300

Malfunction16.6%7,057

Other0%1

Not given0%0

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Stryker Orthopaedics-Mahwah reports

How many FDA device reports name Stryker Orthopaedics-Mahwah as manufacturer?

42,446 reports through August 2026, 1,417 of them in the latest 12 months.

Which of its brands appear most often?

Unknown Reconstructive Product (2,561), Triathlon Ps X3 Tibial Insert (925), Triathlon Cr X3 Tibial Insert (564), Trident 0 X3 Insert 36mm Id (551) and V40 Cocr Lfit Head 36mm/+5 (497).

Which device types does it report on?

prosthesis, hip, semi-constrained, metal/polymer, porous uncemented (24%), prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer (16.8%), prosthesis, hip, semi-constrained, metal/polymer, cemented (15.4%) and prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer (12.7%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.