PINNACLE ALTRX 1221-36-052Recalls & reported problems
Depuy Orthopaedics, Inc. · PINNACLE HIP SOLUTIONS ALTRX POLYETHYLENE ACETABULAR LINER NEUTRAL 36mm ID 52mm 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 is a plastic liner used in hip replacement surgery. Its 477 adverse event reports often describe hip dislocations, infections, and pain that led to revision surgery. There are no deaths and 453 injuries. Reports fell from 56 in the prior 12 months to 28 in the last 12. 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
- 481
- Deaths reported
- 0
- Injuries reported
- 457
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 481 adverse event reports that list this exact device (DI 10603295016328), received between Jun 22, 2017 and Sep 30, 2026 — classified as 457 injuries, 24 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (161 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 Problem253
- Device Dislodged or Dislocated161
- Insufficient Device Problem Information27
- Naturally Worn20
- Difficult to Insert17
- Fracture11
- Disassembly4
- Material Deformation3
Patient problems
- Unspecified Infection163
- Joint Dislocation141
- No Code Available103
- Pain71
- Insufficient Information30
- Joint Laxity24
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available23
- Not Applicable17
Recent adverse event reports
The 25 most recent of 481 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient was revised due to possible infection liner and head removed.DOI: (b)(6) 2026.DOR: (b)(6) 2026. Affected Side: Unknown.
Patient problems: Unspecified Infection
MAUDE report 50945446 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
It was reported that revised head liner to dual mobility for instability. No other information available.DOI: Unknown.DOR: (b)(6) 2026.Affected Side: Right.
Patient problems: Joint Laxity
MAUDE report 50858783 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50828403 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50825447 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
It was reported that washout due to infection. Head and liner removal and reimplantation of same sizes.Affected side: Right hip.
Patient problems: Unspecified Infection
MAUDE report 50805730 ↗InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient was revised due to pain.DOI: Unknown.DOR: (b)(6)2026.Affected Side: Left.
Patient problems: Pain
MAUDE report 50717055 ↗InjuryJul 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PT HAD A THA AND SUBSEQUENT INFECTION. TODAY IN SURGERY, THE WOUND WAS DEBRIDED. A HEAD AND LINER SWAP WAS DONE. AFFECTED SIDE-RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 25908137 ↗InjuryJul 2, 2026Device Dislodged or Dislocated; Naturally Worn
IT WAS REPORTED THAT THE PATIENT HAD A REVISION OF LEFT THA BOTH FEMORAL HEAD AND ACETABULAR LINER DUE TO COMPLAINTS OF PERSISTENT LEFT HIP PAIN. DURING THE PROCEDURE THE ACETABULAR LINER WAS GROSSLY LOOSE AND WAS REMOVED WITH A HAND TOOL. SAUCERIZATION OF LEFT LATERAL FEMORAL CORTEX. TRANSFER OF GLUTEUS MAXIMUS AND TENSOR FASCIA LATA TO GREATER TROCHANTER. PLACEMENT OF SURGEON PREPARED ANTIBIOTIC LOADED BIODEGRADABLE BEADS. DOI: (B)(6) 2019. DOR: (B)(6) 2024. AFFECTED AREA: LEFT HIP.
Patient problems: Joint Laxity; Osteolysis; Pain; Swelling/ Edema
MAUDE report 25691875 ↗InjuryJun 4, 2026Naturally Worn
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO POLY WEAR. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Laxity
MAUDE report 25393557 ↗InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD SUFFERED FROM PAIN DUE TO IMPLANT. AFFECTED SIDE- LEFT KNEE.
Patient problems: Pain
MAUDE report 25391153 ↗InjuryJun 3, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 25375896 ↗InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS REVISED FOR INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 25175271 ↗InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS PAIN. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.
Patient problems: Pain
MAUDE report 25116612 ↗InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT NEEDED MORE STABILITY. DOI: (B)(6) 2019. DOR: (B)(6) 2026. AFFECTED SIDE-RIGHT HIP.
Patient problems: Joint Laxity
MAUDE report 25072780 ↗InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED STATES THAT THE PATIENT EXPERIENCED NO ADVERSE OUTCOMES DUE TO THIS SURGERY.
Patient problems: Joint Laxity
MAUDE report 25035307 ↗MalfunctionApr 28, 2026Break
IT WAS REPORTED ON (B)(6) 2026 THAT THE DEVICE BROKE OFF IN PATIENT WHILE BEING USED TO REDUCE ZMC FRACTURE. SURGERY WAS DELAYED BY 30 MINUTES. BROKEN DEVICE WAS REMOVED FROM PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. FRAGMENTS WERE GENERATED AND THEY WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25017228 ↗InjuryApr 28, 2026Device Dislodged or Dislocated; Material Deformation; Naturally Worn
IT WAS REPORTED THAT POLY WAS CHANGED AND HEAD WAS EXCHANGED. POLY IMPLANT WAS BROKEN AND DEFORMED AFTER DISENGAGEMENT OF LINER. POLYETHYLENE IMPLANT BECAME LOOSE AND BROKE. ALL PIECES WERE RECOVERED. POLY WAS REPLACED WITH A DUAL MOBILITY. NO CEMENT WAS USED AND A PINNACLE 100 CUP WAS USED AND REMAINED IN PLACE. SPINE SURGERY AFTER HIP SURGERY CHANGED THE ORIENTATION OF THE PELVIS CAUSING A CHANGE IN THE ANTEVERSION OF THE ACETABULAR CUP CAUSING MORE EDGE LOADING THEN THE HIP WAS EXPERIENCING PRIOR TO THE SPINE SURGERY FUSING THE LOWER LUMBAR OF THE PATIENT. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.
Patient problems: Insufficient Information
MAUDE report 25015271 ↗InjuryApr 24, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO RECURRING DISLOCATIONS. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: UNKNOWN.
Patient problems: Joint Dislocation
MAUDE report 24985217 ↗InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO HIP INFECTION POLY WAS EXCHANGE. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 24871974 ↗InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT I&D OF HIP. HEAD AND LINER EXCHANGED WHILE IN CAPSULE. AFFECTED SIDE: RIGHT HIP.
Patient problems: Insufficient Information
MAUDE report 24779699 ↗InjuryMar 26, 2026Device Dislodged or Dislocated
PATIENT WAS BEING REVISED DUE TO RECURRENT DISLOCATION. THE 52X36 NEUTRAL LINER AND 36MM 1.5 HEAD WERE REMOVED. DOCTOR IMPLANTED A CONSTRAINED +4 NEUTRAL LINER AND REVISION CERAMIC 32MM +1 FEMORAL HEAD. THERE WAS NO PREVIOUS REVISION. THE PATIENT WAS CONSIDERED TO HAVE RECURRENT DISLOCATIONS BECAUSE THEY HAD PREVIOUSLY DISLOCATED AND THE SURGEON PERFORMED A CLOSED REDUCTION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT.
Patient problems: Joint Dislocation
MAUDE report 24705293 ↗InjuryFeb 25, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO REOCCURRING DISLOCATIONS. NO DAMAGE REPORTED TO IMPLANTS. PATIENT DISLOCATED AND REQUIRED REVISION TO STABILIZE.
Patient problems: Joint Dislocation
MAUDE report 24447436 ↗InjuryFeb 11, 2026Device Dislodged or Dislocated
ADDITIONAL INFORMATION STATES THAT BESIDES INSTABILITY AND NEEDING A REVISION THERE WAS NO OTHER PATIENT CONSEQUENCE.
Patient problems: Insufficient Information; Joint Laxity
MAUDE report 24315582 ↗InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ACETABULAR COMPONENT FAILURE. AFFECTED SIDE: UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 24292114 ↗InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INSTABILITY AND FRACTURE. NO ADDITIONAL INFO. DOI- (B)(6) 2021, DOR- (B)(6) 2026, AFFECTED SIDE- LEFT HIP.
Patient problems: Joint Laxity
MAUDE report 24266682 ↗
Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 reports
- BIOLOX DELTA 1365-40-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented145 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.
How reports and recalls are matched · Editorial policy · Report an error on this page