PINNACLE ALTRX 1221-36-166Recalls & reported problems
Depuy Orthopaedics, Inc. · PINNACLE HIP SOLUTIONS ALTRX POLYETHYLENE ACETABULAR LINER +4 10 DEGREE 36mm ID 66mm OD · Class 2 · Implant
All models of PINNACLE ALTRX (98)
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 10603295016472), received between Jun 28, 2017 and Apr 21, 2025 — 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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Joint Dislocation2
- No Code Available2
- No Information1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryApr 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS DISLOCATING. SURGEON REPLACED LINER WITH CONSTRAINED LINER. THERE WAS NO SURGICAL DELAY OR HARM TO PATIENT. DOI: (B)(6) 2024 DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 21873176 ↗InjuryMay 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2020. AFFECTED SIDE: UNKNOWN.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 10081048 ↗InjuryJan 24, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HAS AMPUTATION ON CONTRALATERAL SIDE OF THA. WHEN HE BENDS OVER TO MESS WITH PROSTHESIS THE HIP WOULD DISLOCATE. CONSTRAINED LINER TO PREVENT FURTHER EVENT OF OCCURRENCE.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 8275940 ↗InjuryJun 28, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated
SURGEON DID THE FIRST LEFT HIP REVISION REMOVING A HOWMEDICA PCA STEM AND CUP ON (B)(6) 2017. DUE TO THE BONE LOSS AND POOR QUALITY SHE DECIDED TO UTILIZE THE LPS PROXIMAL FEMUR AND 66MM MULTIHOLE PINNACLE CUP. THE PATIENT DID WELL UNTIL RECENTLY, TODAY HE HAD A SECOND DISLOCATION WHICH COULD NOT BE REDUCED IN THE ER. WHEN THE SURGEON ENTERED THE JOINT SHE FOUND A LARGE PIECE OF SCAR TISSUE IN THE ACETABULUM. SURGEON REMOVED IT AS WELL AS OTHER TISSUE THAT COULD IMPINGE. THE 36MM HEAD AND LINER WERE REMOVED AND A 40MM HEAD AND LINER WERE USED TO INCREASE STABILITY.
Patient problems: No Information
MAUDE report 6675029 ↗
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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