Device manufacturer, as written on reports
Biomet Orthopedics: medical device reports filed with FDA
34,530 reports name it as the manufacturer of the device involved, 2001–2024.
- 34,530
- reports naming it as manufacturer
- 0.1% of all MAUDE reports
- 0
- reports, 12 months to August 2026
- 3 in the 12 months before
- 4.8%
- classified as malfunction
- 62.3% across all reports
- 0.6%
- classified as death, as reported
- 0.9% across all reports
34,530 medical device reports received by FDA give Biomet Orthopedics as the manufacturer of the device involved, 0.1% of the MAUDE database, from March 2001 to December 2024. 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, against 3 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 (94.5%), malfunction (4.8%) and death (0.6%). 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 | Prosthesis, hip, semi-constrained, metal/polymer, cemented | 1,563 | 5 | 1.9% |
| Unknown Knee | Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer | 909 | 18 | 1.5% |
| M2a-Magnum Pf Cup 52odx46id | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 410 | 13 | 0.4% |
| M2a-Magnum Mod Hd Sz 46mm | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 334 | 13 | 0.5% |
| M2a-Magnum Pf Cup 56odx50id | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 325 | 11 | 0% |
| M2a-Magnum Mod Hd Sz 48mm | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 314 | 23 | 0% |
| M2a-Magnum Pf Cup 54odx48id | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 311 | 21 | 0% |
| M2a-Magnum Pf Cup 50odx44id | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 309 | 12 | 0.2% |
| M2a-Magnum Mod Hd Sz 50mm | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 308 | 11 | 0% |
| M2a-Magnum Mod Hd Sz 44mm | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 280 | 14 | 0.3% |
| M2a 38mm Mod Hd Std Nk | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 262 | 0 | 0% |
| M2a-Magnum Pf Cup 48odx42id | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 207 | 8 | 0% |
| M2a-Magnum Pf Cup 58odx52id | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 206 | 16 | 0.4% |
| Unknown liner | Prosthesis, hip, semi-constrained, metal/polymer, cemented | 204 | 75 | 0.4% |
| Unknown Head | Prosthesis, hip, semi-constrained, metal/polymer, cemented | 193 | 103 | 0.7% |
| Unknown Stem | Prosthesis, hip, semi-constrained, metal/polymer, cemented | 191 | 84 | 0.5% |
| M2a-Magnum Mod Hd Sz 42mm | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 183 | 8 | 0% |
| M2a-Magnum Mod Hd Sz 52mm | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 178 | 17 | 0% |
| M2a 38mm Mod Hd -3mm Nk | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 177 | 0 | 0% |
| M2a 38mm Mod Hd -6mm Nk | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 161 | 0 | 0% |
| M2a-Magnum 42-50 Tpr Insrt Std | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 160 | 15 | 0% |
| M2a-Magnum 42-50mm Tpr Insrt-6 | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 160 | 12 | 1.2% |
| M2a-Magnum 42-50mm Tpr Insrt-3 | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 140 | 5 | 0% |
| Unknown Cup | Prosthesis, hip, semi-constrained, metal/polymer, cemented | 133 | 66 | 0.4% |
| Unknown Extremity | Prosthesis, shoulder, hemi-, humeral, metallic uncemented | 127 | 0 | 1.9% |
| M2a-Magnum Pf Cup 60odx54id | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 103 | 7 | 0.7% |
| Unknown Vanguard Tibial Tray | Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer | 62 | 0 | 7.8% |
| G7 Str Monoblock Shell Insrtr | Prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive | 49 | 9 | 0% |
| Unknown Patella | Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer | 41 | 13 | 1.1% |
| Unknown Femoral Head | Prosthesis, hip, semi-constrained, metal/polymer, cemented | 40 | 8 | 1.4% |
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
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
Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.
Questions about Biomet Orthopedics reports
How many FDA device reports name Biomet Orthopedics as manufacturer?
34,530 reports through August 2026, 0 of them in the latest 12 months.
Which of its brands appear most often?
Unknown Hip (1,563), Unknown Knee (909), M2a-Magnum Pf Cup 52odx46id (410), M2a-Magnum Mod Hd Sz 46mm (334) and M2a-Magnum Pf Cup 56odx50id (325).
Which device types does it report on?
prosthesis, hip, semi-constrained (metal uncemented acetabular component) (36.4%), prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer (16.1%), prosthesis, hip, semi-constrained, metal/polymer, cemented (11%) and prosthesis, hip, semi-constrained, metal/polymer, porous uncemented (8.9%).
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.