Device manufacturer, as written on reports

Depuy Orthopaedics US 1818910: medical device reports filed with FDA

1,532 reports name it as the manufacturer of the device involved, 2011–2019.

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.

1,532
reports naming it as manufacturer: 0% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 41.9%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

1,532 medical device reports received by FDA give Depuy Orthopaedics US 1818910 as the manufacturer of the device involved, 0% of the MAUDE database, from April 2011 to November 2019. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

0 reports arrived in the 12 months to August 2026, and none in 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 (58.1%) and malfunction (41.9%). 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 Hip Femoral Head	Prosthesis, hip, semi-constrained, metal/polymer, cemented	56	176	0.7%
Unknown Hip Acetabular Liners	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	46	260	0.2%
Pinn Straight Cup Impactor	Impactor	40	315	0%
Excel T-Handle	Orthopedic manual surgical instrument	36	150	0%
Unknown Hip Instruments	Orthopedic manual surgical instrument	32	0	0%
Unknown Hip Femoral Stem	Prosthesis, hip, semi-constrained, metal/polymer, cemented	31	79	0.8%
Unknown Knee Tibial Tray	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	30	57	0.2%
Unknown Hip Acetabular Cup	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	26	106	0.4%
Unknown Hip Implant	Prosthesis, hip, semi-constrained, metal/polymer, cemented	26	9	0.6%
Unknown Knee Femoral	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	21	65	0.2%
Quickset 1pc Flex Drill Bit 25	Bit, drill	20	158	0%
Smartset Gmv 40g Us Eo	Bone cement	19	40	0%
Unknown Knee Tibial Insert	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	19	130	0.2%
Quickset Ace Grater Head 45mm	Reamer	18	13	0%
Smartset Mv 40g - Eo	Bone cement	18	4	0.1%
Quickset Ace Grater Head 52mm	Reamer	17	10	0%
Quickset Ace Grater Head 53mm	Reamer	17	10	0%
Quickset Ace Grater Head 55mm	Reamer	14	10	0%
Sp2 Tibial Radel Impactor	Impactor	14	2	0%
Unknown Knee Implant	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	13	16	0%
Quickset Ace Grater Head 44mm	Reamer	12	10	0%
Quickset Ace Grater Head 46mm	Reamer	11	9	0%
Unknown Knee Patella	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	11	26	0.4%
Cor/Tri Ant Stem Insert Shaft	Driver, prosthesis	10	50	0%
Quickset Taper Hex Scdr Rigid	Screwdriver	10	0	0%
Quickset Tprd Hex Scdr U-Joint	Screwdriver	10	12	0%
Hp Mbt Cem Keel Punch Sz 4-7	Orthopedic manual surgical instrument	9	0	0%
Modified Hudson Adapter	Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment	9	0	0%
Quickset Ace Grater Head 49mm	Reamer	9	13	0%
Quickset Ace Grater Head 51mm	Reamer	9	11	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
HTO	Reamer	179	11.7%
LPH	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	167	10.9%
JWH	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	157	10.2%
KWA	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	142	9.3%
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented	133	8.7%
LXH	Orthopedic manual surgical instrument	127	8.3%
HTQ	Broach	57	3.7%
LOD	Bone cement	53	3.5%
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented	50	3.3%
MRA	Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented	50	3.3%

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%0

Injury58.1%890

Malfunction41.9%642

Other0%0

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 Depuy Orthopaedics US 1818910 reports

How many FDA device reports name Depuy Orthopaedics US 1818910 as manufacturer?

1,532 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Unknown Hip Femoral Head (56), Unknown Hip Acetabular Liners (46), Pinn Straight Cup Impactor (40), Excel T-Handle (36) and Unknown Hip Instruments (32).

Which device types does it report on?

reamer (11.7%), prosthesis, hip, semi-constrained, metal/polymer, porous uncemented (10.9%), prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer (10.2%) and prosthesis, hip, semi-constrained (metal uncemented acetabular component) (9.3%).

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.