PCARecalls & reported problems across all models
Howmedica Osteonics Corp. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one PCA model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 2 models of PCA by Howmedica Osteonics Corp. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Oct 17, 2019 and Oct 17, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
PCA recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 30, 2026Open, Classified
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.
Z-3201-2026 · Root cause: Process change control · Recall details · FDA record ↗
Most reported PCA problems
Device problems
- Device Dislodged or Dislocated1
Patient problems
- Injury1
- Joint Dislocation1
PCA models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PCA 6299-N-332Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall0 reports
- PCA 6280-0-136Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
Recent PCA adverse event reports
The 1 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryOct 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
PROCEDURE: THE PATIENT HAD RIGHT HIP REPLACEMENT HISTORY OUTSIDE CORS SCOPE. PATIENT UNDERWENT RIGHT TOTAL HIP REVISION (B)(6) 2018. ONLY HEAD EXCHANGE. THE PATIENT HAD A SECOND DISLOCATION AND SUBSEQUENT RADIOGRAPHS DEMONSTRATED AN INTERVAL CHANGE IN THE POSITION OF THE ACETABULAR HARDWARE WITH FRACTURE OF THE SCREWS CONSISTENT WITH A LOOSE COMPONENT. THE PATIENT UNDERWENT REVISION OF RIGHT TOTAL HIP. CUP, LINER AND HEAD COMPONENTS EXCHANGED (B)(6) 2019.
Patient problems: Injury; Joint Dislocation
MAUDE report 9202460 ↗
Other Howmedica Osteonics Corp. products
- Triathlon608 models · 3,524 reports · 15 recalls
- Scorpio107 models · 113 reports · 28 recalls
- Trident160 models · 1,280 reports · 2 recalls
- Accolade57 models · 1,228 reports
- Duracon58 models · 65 reports · 16 recalls
- LFIT23 models · 852 reports
- TRIDENT II42 models · 188 reports · 12 recalls
- INSTRUMENT131 models · 290 reports · 7 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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