PINNACLE ALTRX 1221-36-154Recalls & reported problems
Depuy Orthopaedics, Inc. · PINNACLE HIP SOLUTIONS ALTRX POLYETHYLENE ACETABULAR LINER +4 10 DEGREE 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 Pinnacle ALTRX hip liner has 231 adverse event reports, including 228 injuries and no deaths. The reports mostly describe the plastic liner coming loose from the cup, the hip dislocating, and patients needing revision surgery, with some infections also reported. No recalls name this device. Reports fell from 18 in the previous 12 months to 8 in the most recent 12 months.
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
- 231
- Deaths reported
- 0
- Injuries reported
- 228
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 231 adverse event reports that list this exact device (DI 10603295016410), received between Aug 3, 2017 and Sep 23, 2026 — classified as 228 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (121 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 Dislocated121
- Adverse Event Without Identified Device or Use Problem91
- Naturally Worn9
- Fracture6
- Insufficient Device Problem Information6
- Noise, Audible4
- Appropriate Device Problem Term/Code Not Available2
- Difficult to Insert2
Patient problems
- Joint Dislocation113
- No Code Available72
- Unspecified Infection39
- Pain37
- Joint Laxity24
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available11
- Foreign Body Reaction8
- Discomfort6
Recent adverse event reports
The 25 most recent of 231 reports, in the reporter's own words as published by the FDA.
InjurySep 23, 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 50870044 ↗InjuryJun 24, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT WAS REVISED AS PATIENT DISLOCATED. 36+5 METAL HEAD AND 36 X 54 +4 10 LINER WERE REVISED. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Joint Dislocation
MAUDE report 25613404 ↗InjuryApr 15, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT CHRONICALLY DISLOCATING. AFFECTED SIDE-RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 24885771 ↗MalfunctionMar 2, 2026Difficult to Insert
IT WAS REPORTED THAT SURGEON TRIED IMPACTING THE PINNACLE ACETABULAR LINER MULTIPLE TIMES, BUT WAS UNABLE TO GET IT TO FULLY SEAT AND LOCK INTO PLACE. THERE WAS NO SOFT TISSUE OR DEBRIS IN THE WAY, ARD'S WERE INTACT AND PROPERLY ALIGNED. SURGEON BELIEVED THE PRODUCT WAS DEFECTIVE. DOE: (B)(6). AFFECTED SIDE: LEFT HIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24489201 ↗InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS INFECTED. THE DEVICES WERE EXPLANTED AND A SPACER WAS IMPLANTED. AFFECTED SIDE-RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 24323869 ↗InjuryFeb 5, 2026Device Dislodged or Dislocated
ADDITIONAL INFORMATION RECEIVED: A. WHAT WAS THE AFFECTED SIDE? LEFT/RIGHT - RIGHT SIDE. B. WAS THE FEMORAL HEAD REPLACE OR STAYED AS IS? - FEMORAL HEAD WAS REPLACED. C. KINDLY CONFIRM IS THERE ANY ALLEGATION AGAINST THE CUP? - NO ALLEGATION AGAINST CUP.
Patient problems: Joint Dislocation
MAUDE report 24270994 ↗InjuryJan 13, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATED. AFFECTED SIDE-RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 24052555 ↗InjuryNov 25, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED BASED ON X-RAY, WE WERE ABLE TO IDENTIFY A SUMMIT/PINNACLE CONSTRUCT SHIFTED. PATIENT UNFORTUNATELY SUFFERED A HIP DISLOCATION, SO DR SCHEDULED THEM FOR A HIP REVISION. WHEN IN THE SURGERY, DR FELT THE CUP POSITIONING WAS IN THE CORRECT INCLINATION AND ANTEVERSION. BECAUSE OF THIS POSITIONING, HE FELT THE PATIENT WOULD BENEFIT FROM CHANGING THE LINER TO A DUAL MOBILITY LINER AND INCREASING THE HEAD LENGTH FROM A 36MM +5 TO A 28MM +8.5 FOR THE DUAL MOBILITY LINER. THE HIP WAS REDUCED AND STABILITY WAS CONFIRMED. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. THE CLOSING PROCESS BEGAN. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 23644563 ↗InjurySep 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO CHRONIC DISLOCATION. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN.
Patient problems: Joint Dislocation
MAUDE report 23005240 ↗InjurySep 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THERE WAS ANTERIOR DISLOCATION TWO WEEKS POST-OP. DETERMINED TO HAVE TOO MUCH CUP ANTIVERSION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 23004223 ↗InjuryAug 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATING HIP. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 22783703 ↗InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S HIP WAS BEING REVISED DUE TO PAIN. SURGEON REMOVED THE 54MM PINNACLE CUP, TWO 30MM PINNACLE SCREW, THE 54- 36MM +410 DEGREE LINER AND THE 36 +8.5 ARTICULEZE HEAD. THESE WERE REPLACED WITH AN EMPHASYS 58MM THREE HOLE CUP, THREE SCREWS, A DUAL MOBILITY LINER AND DUAL MOBILITY HEAD WERE USED. DOI: UNKNOWN. DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Pain
MAUDE report 22636846 ↗InjuryJul 14, 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 JOINT SPACE. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 22493581 ↗InjuryJul 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SOME DISLOCATIONS, SO THE SURGEON PUT IN A CONSTRAINED LINER. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 22468617 ↗InjuryJul 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT'S HIP WAS DISLOCATED. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 22461650 ↗InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD INFECTED HIP. SURGEON PERFORMED I&D OF HIP WITH HEAD/LINER EXCHANGE. THERE WAS NO DELAY AND NO COMPLAINTS. ITEMS UNAVAILABLE FOR RETURN. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 22337316 ↗InjuryJun 16, 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 22210824 ↗InjuryMay 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. THE SURGEON ASKED IF HE COULD HAVE A TS HIP BALL AVAILABLE FOR A REVISION FOR A PATIENT THAT HAS EXPERIENCED A FEW DISLOCATIONS. HIS PLAN WAS TO EXPLANT THE ACETABULAR CUP AND IMPLANT A NEW ONE WHERE HE WAS GOING TO CHANGE THE VERSION. SURGEON EXPLANTED THE FEMORAL HIP BALL, PINNACLE CUP AND LINER. THE SUMMIT STEM WAS LEFT IN SITU, THE LOT # FOR THIS STEM IS UNAVAILABLE. HE IMPLANTED A NEW FEMORAL HIP BALL AND A ZIMMER CUP. ACTIVITY LEVEL - YES. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 22031988 ↗InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INSTABILITY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Laxity
MAUDE report 21988443 ↗InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD AN INFECTION. SO, THE SURGEON DECIDED TO DO A HEAD/POLY EXCHANGE. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 21942556 ↗InjuryMar 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO DISASSOCIATION OF THE LINER FROM THE CUP AFTER 10 YEARS. THE SURGEON BELIEVES IT WAS DUE TO A SPINAL FUSION THAT RECENTLY OCCURRED. THE SURGEON REVISED THE CUP AND USED A DUAL MOBILITY CONSTRUCT. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21582424 ↗InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD A CUP REVISION FOR INSTABILITY. UNKNOWN SURGICAL DELAY. DOI : UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Laxity
MAUDE report 21402128 ↗InjuryJan 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION THREE WEEKS AFTER HER TOTAL HIP. SURGEON DIDN'T KNOW HOW COMPLIANT SHE WOULD BE. SO HE WANTED TO PUT IN A CONSTRAINED LINER. NOTHING WAS MENTIONED OF PROBLEMS WITH THE COMPONENTS. HE REMOVED THE POLY AND THE HEAD. AFTER TRIALING HE REPLACED WITH A CONSTRAINED LINER AND A NEW HEAD. DOI: (B)(6) 2024. DOR: UNKNOWN. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 21220956 ↗InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS REMOVED DUE TO INFECTION, SPACERS IMPLANTED, THERE WAS NO DELAY IN THE CASE AND THE PATIENT WAS NOT HARMED. DOI: UNKNOWN. DOR:(B) (6) 2024. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 21128448 ↗InjuryJan 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO REPEAT DISLOCATIONS. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 21113955 ↗
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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