Device manufacturer, as written on reports

Smith & Nephew Orthopaedics: medical device reports filed with FDA

9,153 reports name it as the manufacturer of the device involved, 1996–2026.

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.

9,153
reports naming it as manufacturer: 0% of all MAUDE reports; 152
reports, 12 months to August 2026: 289 in the 12 months before; 8.2%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

9,153 medical device reports received by FDA give Smith & Nephew Orthopaedics as the manufacturer of the device involved, 0% of the MAUDE database, from January 1996 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

152 reports arrived in the 12 months to August 2026, down 47% from 289 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 (91.6%), malfunction (8.2%) 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
Bhr	Prosthesis, hip, semi-constrained, metal/metal, resurfacing	1,937	0	0%
R3	Prosthesis, hip, semi-constrained, metal/metal, resurfacing	253	0	0.2%
Unkn Birmingham Hip Resurfacing Bhr Cup Unkn Type	Prosthesis, hip, semi-constrained, metal/metal, resurfacing	224	0	0.9%
Polarstem Modular Head For 21000662	Orthopedic manual surgical instrument	180	20	0%
Acetlr Cup Hap 56mm W/ Imptr	Prosthesis, hip, semi-constrained, metal/metal, resurfacing	178	1	0.6%
Acetlr Cup Hap 52mm W/ Imptr	Prosthesis, hip, semi-constrained, metal/metal, resurfacing	167	0	0%
Bhr Acetabular Cup	Prosthesis, hip, semi-constrained, metal/metal, resurfacing	143	0	0%
Plus	Prosthesis, hip, hemi-, trunnion-bearing, femoral, metal/polyacetal	9	0	0.4%
Echelon	Catheter, continuous flush	6	584	3.2%
Reflection	Prosthesis, hip, hemi-, trunnion-bearing, femoral, metal/polyacetal	5	0	0%
Synergy	Coronary drug-eluting stent	5	84	3.5%
Journey	Wire, guide, catheter	3	0	0%
Trigen	Nail, fixation, bone	3	0	0%
Femoral Head	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	1	11	0%
Genesis	Implant, endosseous, root-form	1	0	0.1%
Ni	Set, administration, for peritoneal dialysis, disposable	1	1,587	1.8%

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
NXT	Prosthesis, hip, semi-constrained, metal/metal, resurfacing	5,997	65.5%
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented	745	8.1%
LPH	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	368	4%
LXH	Orthopedic manual surgical instrument	317	3.5%
JDH	Prosthesis, hip, hemi-, trunnion-bearing, femoral, metal/polyacetal	228	2.5%
JWH	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	199	2.2%
KWL	Prosthesis, hip, hemi-, femoral, metal	196	2.1%
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented	185	2%
KWY	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented	184	2%
LWJ	Prosthesis, hip, semi-constrained, metal/polymer, uncemented	129	1.4%

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%21

Injury91.6%8,384

Malfunction8.2%746

Other0%1

Not given0%1

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

Questions about Smith & Nephew Orthopaedics reports

How many FDA device reports name Smith & Nephew Orthopaedics as manufacturer?

9,153 reports through August 2026, 152 of them in the latest 12 months.

Which of its brands appear most often?

Bhr (1,937), R3 (253), Unkn Birmingham Hip Resurfacing Bhr Cup Unkn Type (224), Polarstem Modular Head For 21000662 (180) and Acetlr Cup Hap 56mm W/ Imptr (178).

Which device types does it report on?

prosthesis, hip, semi-constrained, metal/metal, resurfacing (65.5%), prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented (8.1%), prosthesis, hip, semi-constrained, metal/polymer, porous uncemented (4%) and orthopedic manual surgical instrument (3.5%).

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.