PINNACLE 1218-28-250Recalls & reported problems
Depuy Orthopaedics, Inc. · PINNACLE HIP SOLUTIONS GVF POLYETHYLENE ACETABULAR LINER LIPPED 28mm ID 50mm 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 10603295011316), received between Sep 1, 2017 and Jun 4, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
Patient problems
- Foreign Body Reaction1
- Joint Dislocation1
- No Code Available1
- Osteolysis1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED STATES THAT THE SCREWS EXPLANTED WERE NON-DEPUY PRODUCTS AND THE IMPLANTS HAD A RING-SHAPED BLACKENED AS STATED IN THE EVENT.
Patient problems: Foreign Body Reaction; No Code Available; Osteolysis; Pain
MAUDE report 10119692 ↗InjurySep 1, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED TO ADDRESS DUE TO DISLOCATION. UPDATE 8/3/2017. IT IS NOTED WITHIN THE ADDITIONAL INFORMATION THAT A CUP WITH SCREWS WAS ALSO REVISED IN THIS REVISION SURGERY. NO PART AND LOT WERE PROVIDED BUT IT APPEARS THAT IT MAY HAVE BEEN A COMPETITOR CUP AND SCREWS (MAH: KYOCERA)--ADDITIONAL PRODUCT FOLLOW-UP IS BEING INITIATED TO CLARIFY. FURTHER REPORTING MAY FOLLOW BASED UPON ANY INFORMATION RETRIEVED. CURRENTLY, THERE IS NOT ENOUGH INFORMATION TO DETERMINE IF THESE PRODUCTS WERE SOLD IN THE US. COMPLAINT UPDATED ON: 9/1/2017.
Patient problems: Joint Dislocation
MAUDE report 6838248 ↗
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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