PINNACLE 1219-28-060Recalls & reported problems
Depuy Orthopaedics, Inc. · PINNACLE HIP SOLUTIONS MARATHON POLYETHYLENE ACETABULAR LINER NEUTRAL 28mm ID 60mm OD · Class 2 · Implant
All models of PINNACLE (182)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295013341), received between Apr 20, 2018 and Feb 22, 2024 — classified as 4 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated3
- Disassembly1
- Naturally Worn1
Patient problems
- Joint Dislocation3
- No Code Available2
- Joint Laxity1
- Not Applicable1
- Swelling/ Edema1
- Synovitis1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryFeb 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO MULTIPLE RECENT DISLOCATIONS. SURGEON REVISED TO DUAL MOBILITY. SURGICAL DELAY UNKNOWN. DOI: UNKNOWN. DOR: (B)(6)2024. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 18761619 ↗InjuryNov 4, 2021Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn
OPERATIVE NOTES WERE REVIEWED AND INDICATED THAT ON (B)(6) 2021, THE PATIENT HAD A RIGHT REVISION TOTAL HIP TO ADDRESS DISLOCATION, INSTABILITY, ECCENTRIC POLYETHYLENE WEAR. DURING THE REVISION THE SURGEON OBSERVED EFFUSION, FOREIGN BODY SYNOVITIS. THERE WAS SOME CORROSION ON THE TRUNNION. THE FEMORAL HEAD AND LINER WERE REVISED. DEPUY COMPONENTS WERE USED DURING THIS PROCEDURE.
Patient problems: Joint Dislocation; Joint Laxity; Swelling/ Edema; Synovitis
MAUDE report 12752505 ↗InjuryMar 27, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE REVISION WAS DUE TO DISLOCATIONS. NO INSTRUMENTS WERE BROKEN DURING SURGERY. DOI: UNKNOWN. DOR: (B)(6) 2019; RIGHT HIP.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 8455375 ↗InjuryApr 20, 2018Disassembly; Disassembly
DER STATED THAT POLY SPUN OUT OF CUP. DOI: APPROX. 15 YEARS AGO; DOR (B)(6) 2018; UNKNOWN SIDE.
Patient problems: No Code Available; Not Applicable
MAUDE report 7446817 ↗
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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