PINNACLE ALTRX 1221-36-454Recalls & reported problems
Depuy Orthopaedics, Inc. · PINNACLE HIP SOLUTIONS ALTRX POLYETHYLENE ACETABULAR LINER +4 NEUTRAL 36mm ID 54mm 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 polyethylene hip liner is used in total hip replacement. Its 242 reports, mostly injury reports, describe hip dislocations, joint infections and unstable hips that led to revision surgery. The reports include 240 injuries and no deaths. 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
- 244
- Deaths reported
- 0
- Injuries reported
- 242
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 244 adverse event reports that list this exact device (DI 10603295016496), received between Aug 30, 2017 and Sep 16, 2026 — classified as 242 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (95 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
- Adverse Event Without Identified Device or Use Problem129
- Device Dislodged or Dislocated95
- Insufficient Device Problem Information15
- Appropriate Device Problem Term/Code Not Available3
- Fracture3
- Naturally Worn2
- Noise, Audible2
- Material Disintegration1
Patient problems
- Joint Dislocation92
- Unspecified Infection82
- No Code Available73
- Pain36
- Joint Laxity24
- Discomfort6
- Not Applicable6
- Tissue Damage6
Recent adverse event reports
The 25 most recent of 244 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient came in with an infected right hip. The patient had all hip implants and placing cement spacer removed. There was no delay in case.DOI- (b)(6)2021.DOR- (b)(6)2026.Affected side- Right Hip.
Patient problems: Unspecified Infection
MAUDE report 50791203 ↗InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient returned to surgery for a draining wound hematoma. The wound was irrigated and debrided. The head and liner were swapped.Affected side- Right Hip.
Patient problems: Fluid Discharge; Hematoma
MAUDE report 50117880 ↗InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INFECTED THA. DOI: UNKNOWN . DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 25670699 ↗InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD POSSIBLE INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT.
Patient problems: Unspecified Infection
MAUDE report 25355502 ↗InjuryMay 12, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO JOINT INFECTION AND DISLOCATION, SCREW WAS REMOVED AND HEAD AND POLY WERE CHANGED FOR DUAL MOBILITY CONSTRUCT. ALL PARTS WERE INTACT. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation; Unspecified Infection
MAUDE report 25149715 ↗InjuryMay 1, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT RETURN TO SURGERY FOR DISLOCATIONS AND INSTABILITY. THE HEAD AND LINER WERE REVISED. DOI- (B)(6) 2025. DOR- (B)(6) 2026. AFFECTED SIDE-RIGHT HIP.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 25057331 ↗InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE TOTAL HIP WAS UNSTABLE. CONVERTED TO DUAL MOBILITY AND LONGER HEAD. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Laxity
MAUDE report 25055254 ↗InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD A LEFT TOTAL HIP DONE BY SURGEON IN (B)(6) 2024. PATIENT CAME IN WITH A HIP INFECTION AND REMOVAL OF IMPLANTS AND ANTIBIOTIC SPACER WAS IMPLANTED. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 24999740 ↗InjuryApr 24, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HIP DISLOCATION. THE IMPLANTS WERE IDENTIFIED VIA X-RAYS, AND A HEAD AND LINER EXCHANGE WAS PERFORMED USING A CONSTRAINED LINER. A 36+0 HEAD AND A 54 +4 NEUTRAL LINER WERE REMOVED AND REPLACED AFTER CONFIRMING HIP STABILITY. DOI: UNKNOWN, DOR: APR 09, 2026, AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 24988268 ↗InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WANTED MORE LEG LENGTH. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT HIP.
Patient problems: Physical Asymmetry
MAUDE report 24680985 ↗InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT COMES IN TODAY WITH CONSISTENT THIGH PAIN. THE DOCTOR FOUND IT BEST TO REMOVE THE STEM AND REPLACE IT WITH A RECLAIM MONO. THE DOCTOR ALSO DECIDED TO SWAP THE LINER WHILE REPLACING THE STEM. AFFECTED SIDE-RIGHT HIP
Patient problems: Pain
MAUDE report 24603957 ↗InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Laxity
MAUDE report 24544587 ↗InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT INFECTED HIP DOI: UNKNOWN, DOR: ON (B)(6) 2026, AFFECTED SIDE: UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 24489717 ↗InjuryFeb 26, 2026Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO CUP WAS MALPOSITIONED, CREATING CHRONIC DISLOCATION. 54 CUP REMOVED, LINER REMOVED, HEAD REMOVED. CUP REVISION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT.
Patient problems: Joint Dislocation
MAUDE report 24458146 ↗InjuryFeb 4, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE SURGEON CHOSE TO CONVERT TO DUAL MOBILITY FOLLOWING A DISLOCATION. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 24258276 ↗InjuryJan 29, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE HIP WAS DISLOCATED. THERE WAS NO DELAY AND NO HARM TO PATIENT. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 24212892 ↗InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT REVISED FOR INSTABILITY. NO IMPLANT ISSUES. NO OTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2014, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Laxity
MAUDE report 24006202 ↗InjuryDec 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS IMPINGEMENT ON THE LINER. SURGEON REPLACED THE CERAMIC HEAD, CUP AND LINER DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.
Patient problems: Joint Laxity
MAUDE report 23898883 ↗InjuryNov 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE DISLOCATION WAS REOCCURRING. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 23496223 ↗InjuryNov 4, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q3 OF 2025. DARTHMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO INFECTION AND PAIN. MINOR METAL TRANSFER WAS NOTED ON THE FEMORAL HEAD. ACETABULAR LINER SHOWED MODERATE YELLOWING.
Patient problems: Pain; Unspecified Infection
MAUDE report 23465192 ↗InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT LINER AND HEAD WERE REMOVED AND REPLACED TO ACHIEVE ADDITIONAL LENGTH AND OFFSET. AFFECTED SIDE: RIGHT HIP.
Patient problems: Physical Asymmetry
MAUDE report 22871484 ↗InjuryJul 31, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. AFFECTED SIDE: UNKNOWN.
Patient problems: Joint Dislocation
MAUDE report 22674729 ↗InjuryJul 16, 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 INFECTED HIP. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 22522117 ↗InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S IMPLANTS REMOVED DUE TO INFECTED HIP, PLACED PROSTHETIC, STEM, AND ALL POLY LINER. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 22358333 ↗InjuryJun 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO RECURRENT DISLOCATION. DOI: (B)(6) 2019. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 22340826 ↗
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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