PINNACLE ALTRX 1221-36-064Recalls & reported problems
Depuy Orthopaedics, Inc. · PINNACLE HIP SOLUTIONS ALTRX POLYETHYLENE ACETABULAR LINER NEUTRAL 36mm ID 64mm OD · Class 2 · Implant
All models of PINNACLE ALTRX (98)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295016380), received between Oct 13, 2017 and Sep 28, 2026 — classified as 11 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 Dislocated6
- Adverse Event Without Identified Device or Use Problem5
- Fracture1
- Naturally Worn1
Patient problems
- Unspecified Infection4
- Joint Dislocation3
- No Code Available2
- Pain2
- Insufficient Information1
- Osteolysis1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient was revised due to infection.Affected side-Right hip.
Patient problems: Unspecified Infection
MAUDE report 50920689 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that Head and liner were removed and replaced with washout for infection.Affected Side: Unknown.
Patient problems: Unspecified Infection
MAUDE report 50917560 ↗InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT HIP.
Patient problems: Pain
MAUDE report 21610712 ↗InjuryDec 26, 2024Fracture; Device Dislodged or Dislocated; Naturally Worn; Fracture; Device Dislodged or Dislocated; Naturally Worn
IT WAS REPORTED THAT THERE WAS A HEAD BALL AND LINER EXCHANGE ON A PATIENT WHO HAD COME BACK IN DUE TO PAIN. THE LINER FOR CUP HAD POPPED OUT. THE STEM AND HEAD BALL WERE SITTING SUPERIOR IN CUP. THE HEAD BALL SHOWED WEAR AND LINER SHOWED WEAR AS WELL WITH POSSIBLE BROKEN TAB. THE INITIAL SURGERY WAS THREE YEARS PRIOR TO THE REVISED DATE OF (B)(6) 2024, THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: Pain
MAUDE report 21018720 ↗InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD A LEFT HIP REVISION DUE TO DISLOCATED HIP. A NEW PINNACLE LINER AND SROM CERAMIC HEAD WERE IMPLANTED AT THAT TIME. THE PATIENTS PREVIOUS SURGERY WAS DONE IN BALTIMORE YEARS AGO. THE PATIENT IS NOW INFECTED AND CAME IN FOR RESECTION WITH PROSTALAC SPACER INSERTION. SURGICAL DELAY UNKNOWN. (B)(6). AFFECTED SIDE: LEFT HIP
Patient problems: Unspecified Infection
MAUDE report 18488476 ↗InjuryJan 24, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
REVISION COMPLETED DUE TO DISASSOCIATION OF LINER FIVE YEARS POST INITIAL SURGERY. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 13335077 ↗InjuryAug 31, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENTS HIP DISLOCATED TWICE. THE SURGEON DECIDED TO IMPLANT A CONSTRAINED LINER. 64+4 10 DEGREE AND A 40+9 H. DOI: (B)(6) 2021 - DOR: (B)(6) 2021 (RIGHT HIP).
Patient problems: Joint Dislocation
MAUDE report 12392407 ↗InjuryApr 1, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED TO ADDRESS LINER DISASSOCIATION. DOI: (B)(6) 2019. DOR: (B)(6) 2020. AFFECTED SIDE: LEFT HIP.
Patient problems: No Code Available
MAUDE report 9911643 ↗InjuryMay 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED TO ADDRESS INFECTION.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 8603236 ↗InjuryNov 16, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED DUE TO RECURRING DISLOCATIONS. THE SURGEON SAID THERE WERE NO ISSUES WITH THE IMPLANTS.
Patient problems: Joint Dislocation
MAUDE report 7039954 ↗InjuryOct 13, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS OF ACETABULUM AND PERIPROSTHETIC DISLOCATION OF HIP JOINT. ALL ACETABULUM COMPONENTS WERE REMOVED AND ANOTHER COMPANY'S PRODUCTS WERE USED FOR THE REVISION.
Patient problems: Joint Dislocation; Osteolysis
MAUDE report 6948122 ↗
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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