PINNACLE 1219-28-454Recalls & reported problems
Depuy Orthopaedics, Inc. · PINNACLE HIP SOLUTIONS MARATHON POLYETHYLENE ACETABULAR LINER +4 NEUTRAL 28mm ID 54mm OD · Class 2 · Implant
All models of PINNACLE (182)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295013785), received between Feb 15, 2019 and Mar 23, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).
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
- Device Dislodged or Dislocated2
- Naturally Worn1
Patient problems
- Joint Dislocation2
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 23, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR RECURRENT DISLOCATION. NO ADDUCTOR ATTACHMENT. THERE WAS NO SUGGESTION THAT THE PRODUCT DID NOT WORK AS INTENDED. THERE WERE NO PRIOR REVISION SURGERIES. THE LOT NUMBER IS FROM THE POLY ITSELF, POSSIBLY THE NUMBERS WERE WORN. PATENT HAD THREE CLOSED REDUCTIONS IN THE WEEKS LEADING UP TO THE REVISION. PATIENT THOUGHT THE INDEX PROCEDURE WAS 18-20 YEARS AGO. DOI: (B)(6) 2003; DOR: (B)(6) 2021: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 11553924 ↗InjuryFeb 15, 2019Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn
IT WAS REPORTED THAT THE PATIENT STARTED DISLOCATING 16 YEARS FOLLOWING THA. SURGEON REMOVED PINNACLE LINE AND FEMORAL HEAD.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 8342873 ↗
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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