PCA Head 2284-0-428Recalls & reported problems
Howmedica Osteonics Corp. · Femoral Head Component · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327012774), received between Nov 11, 2020 and Nov 11, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Corroded” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Corroded1
- Device Dislodged or Dislocated1
Patient problems
- Inflammation1
- Joint Dislocation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 11, 2020Corroded; Device Dislodged or Dislocated; Corroded; Device Dislodged or Dislocated
REVISION SURGERY. LAST REVISION WAS COMPLETED ON (B)(6)2011. UPON SURGERY, IT WAS NOTICED THAT THE FEMORAL HEAD DISASSOCIATED WITH THE OUTER HEAD COMPONENT. SEVERE METALLOSIS WAS NOTED. LEFT SIDE. UPDATE: ORIGINAL REVISION DATE WAS 11/21/11. NO OP-NOTES OR ANY OTHER INFORMATION FROM THE PHYSICIAN. THE LAST REVISION WHEN THE IMPLANTS WERE RETRIEVED ((B)(6)2020), IT WAS CLEAR THE INNER PCA HEAD WAS DISASSOCIATED WITH THE OUTER MDM HEAD (AS EVIDENCED BY THE X RAY). THE PCA HEAD WAS ARTICULATING ON THE MDM METAL LINER INSIDE THE CUP. THE TISSUE WAS GRAY AS WAS FLUID INSIDE THE JOINT WHICH WAS SUCTIONED OUT.
Patient problems: Inflammation; Joint Dislocation
MAUDE report 10821470 ↗
Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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