PINNACLE ALTRX 1221-32-450Recalls & reported problems
Depuy Orthopaedics, Inc. · PINNACLE HIP SOLUTIONS ALTRX POLYETHYLENE ACETABULAR LINER +4 NEUTRAL 32mm ID 50mm OD · Class 2 · Implant
All models of PINNACLE ALTRX (98)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Pinnacle AltRx hip liner, an implant used in hip replacement, has 213 adverse event reports, with no deaths and 208 injuries. Many describe the hip dislocating, and some patients needed revision surgery to replace the head or liner, while a few mention a liner breaking apart. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 215
- Deaths reported
- 0
- Injuries reported
- 210
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 215 adverse event reports that list this exact device (DI 10603295016281), received between Jun 23, 2017 and Sep 15, 2026 — classified as 210 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (128 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 Dislocated128
- Adverse Event Without Identified Device or Use Problem66
- Insufficient Device Problem Information13
- Naturally Worn4
- Manufacturing, Packaging or Shipping Problem3
- Noise, Audible3
- Difficult to Insert2
- Disassembly2
Patient problems
- Joint Dislocation120
- No Code Available63
- Unspecified Infection36
- Pain35
- Joint Laxity19
- Not Applicable8
- Insufficient Information7
- Tissue Damage7
Recent adverse event reports
The 25 most recent of 215 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient was unstable.DOI: (b)(6), 2024DOR: (b)(6), 2026Affected side: Unknown.
Patient problems: Joint Laxity
MAUDE report 50775556 ↗InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient needed revision due to instability.DOI: (b)(6) 2019.DOR: (b)(6) 2026.Affected side: Left hip
Patient problems: Joint Laxity
MAUDE report 50061400 ↗InjuryJun 8, 2026Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO DISLOCATION. SURGEON REPLACED HEAD AND LINER AND DEEMED HIP TO BE STABLE. THERE WERE NO DELAYS OR COMPLAINTS AND NO HARM TO THE PATIENT. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 25428538 ↗InjuryMar 4, 2026Device Dislodged or Dislocated
ADDITIONAL INFORMATION RECEIVED: A. KINDLY CONFIRM IS THERE ANY ALLEGATION AGAINST THE CUP? - NO ALLEGATIONS ON ANY IMPLANT.
Patient problems: Joint Dislocation
MAUDE report 24506594 ↗InjuryFeb 19, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE LINER BROKE APART. DOI- UNKNOWN. DOR-(B)(6) 2026. AFFECTED SIDE- RIGHT HIP.
Patient problems: Insufficient Information
MAUDE report 24386278 ↗InjuryDec 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2016. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 23905860 ↗InjuryNov 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO DISASSOCIATED ACETABULAR LINER. CHANGED HEAD AND LINER. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.
Patient problems: Insufficient Information
MAUDE report 23575017 ↗InjuryNov 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO CHRONIC DISLOCATION. THIS IS THE ONLY INFORMATION AVAILABLE TO REPORT. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 23479701 ↗InjuryOct 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 23381838 ↗InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT PRESENTED WITH PAIN AND FEELING UNSTABLE. UPON X-RAY THE DOCTOR FOUND POSSIBLE CALCAR FRACTURE AND STEM SUBSIDED. SURGERY WAS SCHEDULED. STEM WAS REMOVED AND REPLACED. CUP WAS WELL FIXED. REPLACED NEUTRAL LINER WITH A 10 DEGREE LINER AND CHANGED HEAD BALL. SURGERY WAS SUCCESSFUL. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Laxity; Pain
MAUDE report 23061755 ↗InjuryJul 31, 2025Adverse 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 PAINFUL HIP. AFFECTED SIDE: RIGHT HIP.
Patient problems: Pain
MAUDE report 22677976 ↗InjuryJul 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HAD DISLOCATED 8 TIMES, AND THE SURGEON SWITCHED OUT THE LINER AND HEAD. THIS WAS THE FIRST REVISION SURGERY. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 22470167 ↗InjuryJul 10, 2025Adverse 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 OF HIP. SURGEON DID A WASHOUT AND REMOVED THE EXISTING HEADBALL AND LINER AND REPLACED WITH SAME SIZE LINER AND A TS HEADBALL. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Unspecified Infection
MAUDE report 22469932 ↗InjuryJun 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 22308494 ↗InjuryJun 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A DISLOCATION. DURING SURGERY, X-RAYS SHOWED ALL IMPLANTS PROPERLY INSERTED AND WELL FIXED. SURGEON REDUCED PATIENT AND COULD NOT MAKE DISLOCATE THROUGH NORMAL TRIALS AND RANGE OF MOTION. PATIENT HAS HAD PREVIOUS SPINAL SURGERY AND HARDWARE. SURGEON DECIDED TO GO WITH A CONSTRAINED LINER A SLIGHTLY LONGER HEAD BALL. SURGERY WAS SUCCESSFUL AND NO ADVERSE EFFECTS ON PATIENT. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 22212653 ↗InjuryJun 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED DUE TO CHRONIC DISLOCATION. DOI: (B)(6) 2017, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 22188307 ↗InjuryApr 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT KEEPS DISLOCATING. DOI: ON (B)(6) 2025, DOR: ON (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 21899059 ↗InjuryJan 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO MULTIPLE DISLOCATIONS. THEY REMOVED THE CUP AND REPLACED IT WITH A ZB CUP/DM. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 21138252 ↗InjuryDec 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED, THAT THE PATIENT DISLOCATED TWO TIMES. SO, CONVERTED TO A CONSTRAINED LINER. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 20870429 ↗InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT LEFT HIP WAS REVISED ON (B)(6) 2024 DUE TO INFECTION. SURGEON REMOVED HEAD AND LINER AND REPLACED WITH NEW. DATE OF IMPLANT WAS (B)(6) 2024
Patient problems: Unspecified Infection
MAUDE report 20446646 ↗InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT WAS REVISED DUE TO INSTABILITY. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Laxity
MAUDE report 20400088 ↗InjurySep 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT WAS REVISED TO CHANGE OUT HEAD AND LINER TO DUAL MOBILITY DUE TO DISLOCATIONS. DOI: (B)(6) 2024 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 20321316 ↗InjurySep 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT KEEPS DISLOCATING AND GOING TO REPLACE THE LINER TO A CONSTRAINED LINER. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 20152358 ↗InjuryAug 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS UNSTABLE SO THE DOCTOR SENT AND AND SWAPPED THE HEAD AND THE POLY FOR A DUAL MOBILITY CONSTRUCT. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2009. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.
Patient problems: Joint Laxity
MAUDE report 20004163 ↗InjuryJul 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS DISLOCATED. PUT IN CONSTRAINED LINER. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 19760683 ↗
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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