PINNACLE ALTRX 1221-32-058Recalls & reported problems
Depuy Orthopaedics, Inc. · PINNACLE HIP SOLUTIONS ALTRX POLYETHYLENE ACETABULAR LINER NEUTRAL 32mm ID 58mm OD · Class 2 · Implant
All models of PINNACLE ALTRX (98)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295016144), received between Oct 18, 2017 and Aug 9, 2023 — classified as 8 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 Dislocated5
- Adverse Event Without Identified Device or Use Problem2
- Disassembly1
Patient problems
- No Code Available3
- Pain3
- Insufficient Information1
- Joint Dislocation1
- Joint Laxity1
- No Information1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO PAIN. NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.
Patient problems: Pain
MAUDE report 17487776 ↗InjuryAug 24, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT ACETABULAR POLY AND FEMORAL HEAD WAS REVISED DUE TO POLY DISASSOCIATION. DOI: (B)(6) 2017. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.
Patient problems: Insufficient Information
MAUDE report 15282006 ↗InjurySep 13, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
COMPASS CASE (B)(4) REPORTS: THE PATIENT WAS REVISED TO ADDRESS DISLOCATION AND INSTABILITY. SURGEON REMOVED LINER AND CONVERTED TO PINNACLE MDM LINER. NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2021, LEFT HIP.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 12463921 ↗InjuryMar 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2014, DOR: (B)(6) 2021, RIGHT HIP.
Patient problems: Pain
MAUDE report 11530013 ↗InjuryOct 19, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HAD A LEFT THA DONE IN 2013 USING PINNACLE AND SROM. PATIENT PRESENTED WITH SUDDEN PAIN AND GRINDING. PATIENT HAS DISSOCIATED THE PINNACLE LINER. A NEW PINNACLE LINER WAS PLACED AND A NEW SROM HEAD WAS ALSO PLACED. DOI: 2013, DOR: (B)(6) 2020, AFFECTED SIDE: UNKNOWN.
Patient problems: No Code Available; Pain
MAUDE report 10696742 ↗InjuryJul 10, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
ADDITIONAL INFORMATION RECEIVED STATED THAT THE AFFECTED SIDE IS THE LEFT. THERE WAS NO SURGICAL DELAY.
Patient problems: No Code Available
MAUDE report 10259862 ↗InjuryDec 10, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
3 YEARS AFTER IMPLANTATION, PATIENT PRESENTED WITH A LINER DISSOCIATION. THE PATIENT HAD A 58MM PINNACLE CUP WITH A 32MM ALTREX NEUTRAL LINER. SURGEON REVISED THE PATIENT. THE REVISION WAS THE REPLACEMENT OF THE HEAD AND LINER. REVISED WITH A 58/36 ALTREX NEUTRAL LINER.
Patient problems: No Code Available
MAUDE report 9443553 ↗InjuryOct 18, 2017Disassembly; Disassembly
THE PATIENT WAS REVISED TO ADDRESS ALTREX LINER DISSOCIATION FROM THE PINNACLE CUP. SURGEON IMPLANTED A NEW LINER AND HEAD.
Patient problems: No Information
MAUDE report 6959649 ↗
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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