Devices › Prosthesis, knee, hemi-, tibial, resurfacing (uncemented)
Device brand name · Ringloc bi-polar femoral cup
Biomet: medical device reports filed with FDA
337 reports name it, 1994–2018. Manufacturer given most often on reports: Biomet. Product code HSH.
- 337
- device reports naming the brand
- 0% of all MAUDE reports · about 10 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 20.5%
- classified as malfunction
- 13.3% across the product code
- 0.3%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 337 reports that name the brand "Biomet" (ringloc bi-polar femoral cup), received between January 1994 and September 2018; the manufacturer given most often on reports is Biomet. Spellings of one product vary from report to report.
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 (72.4%), malfunction (20.5%) and other (4.7%); across all prosthesis, knee, hemi-, tibial, resurfacing (uncemented) reports (product code HSH) death is recorded in 0.1% and malfunction in 13.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are explanted (46.3%), replace (23.1%) and break (15.4%). The patient problems coded most often are surgical procedure, repeated, pain and surgical procedure. 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."
Reports by month, five years
No report naming Biomet was received in the five years to August 2026; the latest was received in September 2018.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 8,111 reports carrying product code HSH. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Explanted | 156 | 46.3% | 46.3% |
| Replace | 78 | 23.1% | 26.1% |
| Breakthe device broke | 52 | 15.4% | 3.6% |
| Loose | 36 | 10.7% | 17.5% |
| Fracturea broken bone | 35 | 10.4% | 2.6% |
| Device issuea problem with the device | 23 | 6.8% | 1.5% |
| Dislocated | 21 | 6.2% | 1.5% |
| Component(s), worn | 16 | 4.7% | 16.7% |
| Component(s), broken | 15 | 4.5% | 1.5% |
| Implant, removal of | 15 | 4.5% | 18.3% |
| Device, or device fragments remain in patient | 13 | 3.9% | 0.5% |
| Device remains implanted | 11 | 3.3% | 1.3% |
| Detachment of device component | 8 | 2.4% | 0.5% |
| Difficult to removethe device was hard to remove | 7 | 2.1% | 0% |
| Dislodged | 6 | 1.8% | 0.4% |
| Other (for use when an appropriate device code cannot be identified) | 5 | 1.5% | 2.7% |
| Sticking | 5 | 1.5% | 0.1% |
| Tip breakage | 5 | 1.5% | 0% |
| Crackthe device cracked | 4 | 1.2% | 0.4% |
| Device slipped | 4 | 1.2% | 1.7% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Surgical procedure, repeated | 104 | 30.9% |
| Painpain, site not specified | 84 | 24.9% |
| Surgical procedure | 84 | 24.9% |
| Hospitalization required | 41 | 12.2% |
| Therapy/non-surgical treatment, additional | 33 | 9.8% |
| Arthralgiajoint pain | 31 | 9.2% |
| Failure of implant | 22 | 6.5% |
| Nonresorbable materials, unretrieved in body | 15 | 4.5% |
| Other (for use when an appropriate patient code cannot be identified) | 15 | 4.5% |
| Joint dislocationa dislocated joint | 12 | 3.6% |
| Loss of range of motion | 9 | 2.7% |
| Surgical procedure, additional | 8 | 2.4% |
| Foreign body reaction | 7 | 2.1% |
| Hip fracturea broken hip | 7 | 2.1% |
| Ambulation or postural difficulties | 5 | 1.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Biomet | Product code HSH | All MAUDE reports |
|---|---|---|---|
| Reports | 337 | 8,111 | 26,136,888 |
| Share of that pool | — | 4.2% | 0% |
| Classified as death, per 1,000 reports | 3 | 1 | 9 |
| Classified as injury | 72.4% | 80.6% | 36.2% |
| Classified as malfunction | 20.5% | 13.3% | 62.3% |
| Filed by the manufacturer | 0.6% | 89.7% | 94.9% |
Shares are of reports, not 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."
Other brands with product code HSH
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Unknown Depuy Insert | 520 | 0 | 0% |
| Unknown Depuy Tibial Tray | 633 | 0 | 0% |
| Unknown Depuy Tibial Insert | 728 | 0 | 0% |
| Foundation Knee System | 371 | 0 | 0% |
| Zimmer | 1,159 | 0 | 2.8% |
| Unk Depuy Insert | 191 | 0 | 0% |
| Genesis | 1,648 | 0 | 0.1% |
| Series 7000 Standard Tibia | 293 | 0 | 0% |
| Journey | 256 | 0 | 0% |
| Optetrak | 710 | 15 | 0% |
| Triathlon Cr X3 Tibial Insert | 723 | 13 | 0% |
| Mbt Cem Keel Tib Tray Sz3 | 1,085 | 9 | 0% |
| Pca Knee | 165 | 0 | 0% |
| Triathlon Ps X3 Tibial Insert | 1,106 | 21 | 0% |
| Profix | 823 | 0 | 0% |
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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Biomet reports
How many FDA reports name Biomet?
337 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (72.4%), malfunction (20.5%) and other (4.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
explanted (46.3%), replace (23.1%), break (15.4%), loose (10.7%) and fracture (10.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
voluntary reports (33.2%) and manufacturer reports (0.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Biomet was at fault?
No. 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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.