PINNACLE 1217-11-054Recalls & reported problems
Depuy Orthopaedics, Inc. · PINNACLE HIP SOLUTIONS DUOFIX HA ACETABULAR SHELL 100 SERIES 54mm 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 10603295009078), received between Mar 13, 2020 and Feb 3, 2026 — classified as 4 injuries.
The most frequently reported specific device problem is “Malposition of Device” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Malposition of Device1
- Migration1
- Use of Device Problem1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Foreign Body Reaction1
- Insufficient Information1
- Joint Disorder1
- No Code Available1
- Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryFeb 3, 2026Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT THE HIP REVISION PROCEDURE DUE TO MIGRATION OF THE PINNACLE ACETABULAR CUP. THE STEM CAME OUT WHEN THE HEAD WAS REMOVED, THEREFORE THE STEM WAS REPLACED AS WELL. IMPLANTS WERE REPLACED WITH PINNACLE MULTIHOLE SZ 56, +4/10 LINER, 36 +12 CERAMIC HEAD AND C-STEM SZ 2 HIGH OFFSET.
Patient problems: Insufficient Information
MAUDE report 24247785 ↗InjuryJun 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION CASE DUE TO INFECTION ON (B)(6) 2021. THE CASE HAD OCCURRED AND ALL IMPLANTS REMOVED DUE TO INFECTION BEING PRESENT. COMPETITOR IMPLANTS CEMENTED INSITU FOR 1ST STAGE REVISION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12025680 ↗InjuryDec 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE ACETABULAR CUP, CERAMIC INSERT AND CERAMIC FEMORAL HEAD WERE REMOVED, AND REPLACED WITH COMPETITOR PRODUCTS. THE SURGEON STATED THAT PREVIOUS SURGEON, USAGE AND SURGERY DATE WERE UNKNOWN AS HE HAD INHERITED THE PATIENT.
Patient problems: Pain
MAUDE report 11065841 ↗InjuryMar 13, 2020Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device
THE CASE WAS A HEAD AND LINER EXCHANGE FOR IMPINGEMENT. DETAILS ¿ IMPLANTS INSITU. WERE CERAMIC ON CERAMIC, CUP WAS MAL-POSITIONED CAUSING IMPINGEMENT AND SQUEAKING. UPON DISSECTION NOTICED METALLOSIS FROM STEM NECK IMPINGING ON RIM OF CUP. REMOVED CERAMIC LINER AND HEAD AND REPLACED WITH A +4 NEUTRAL POLY LINER AND TS CERAMIC HEAD. IMPLANT DETAILS FOR EXTRACTION AND INSERTION ATTACHED.
Patient problems: Foreign Body Reaction; Joint Disorder; No Code Available
MAUDE report 9831859 ↗
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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