PINNACLE 1217-07-060Recalls & reported problems
Depuy Orthopaedics, Inc. · PINNACLE HIP SOLUTIONS REVISION POROCOAT (DPX) ACETABULAR SHELL DEEP PROFILE 60mm OD 54mm LINER · 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 10603295008903), received between May 25, 2018 and Dec 6, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
- Loss of Osseointegration1
Patient problems
- Inadequate Osseointegration2
- No Code Available1
- Not Applicable1
- Pain1
- Swelling1
- Tissue Damage1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 6, 2018Loss of Osseointegration; Loss of Osseointegration
LITIGATION ALLEGES THAT PATIENT EXPERIENCED PAIN AROUND THE HIP JOINT, DIFFICULTY WALKING, MUSCLE AND BONE SEPARATION AND SWELLING. UPDATE AFTER REVIEW OF THE MEDICAL RECORDS, THE REVISION SURGERY NOTES METALLOSIS, AND THE PATIENT DISLOCATED ONCE. UPDATE IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES METAL WEAR AND LOOSENING OF CUP. DOI: (B)(6) 2007- DOR: (B)(6) 2015 (LEFT HIP).
Patient problems: Inadequate Osseointegration; No Code Available; Pain; Swelling; Tissue Damage
MAUDE report 8137164 ↗InjuryMay 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
PPF AND MEDICAL RECORDS RECEIVED. PLAINTIFF PROFILE FORM ALLEGES LOOSENING OF CUP, INFECTION, LOOSENING OF STEM. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY, IT WAS DETERMINED THAT THE PATIENT HAD A TWO STAGE REVISION DUE TO INFECTION FROM THE PREVIOUS UNKNOWN MANUFACTURER HIP IMPLANT WITH THE FIRST STAGE REVISION TO A TOTAL DEPUY HIP. REVISION NOTES REPORTED THAT THE PATIENT UNDERWENT THE SECOND STAGE REVISION, AND ALL THE FEMORAL AND ACETABULAR COMPONENTS WERE REVISED TO A COMPETITOR HIP. THERE WERE NO INDICATIONS OF LOOSENING AND INFECTION FOR THE REVISED DEPUY IMPLANTS. DOI: (B)(6) 2007; DOR: (B)(6) 2013; RIGHT HIP.
Patient problems: Inadequate Osseointegration; Not Applicable; Unspecified Infection
MAUDE report 7544451 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page