PINNACLE ALTRX 1221-28-250Recalls & reported problems
Depuy Orthopaedics, Inc. · PINNACLE HIP SOLUTIONS ALTRX POLYETHYLENE ACETABULAR LINER LIPPED 28mm ID 50mm OD · Class 2 · Implant
All models of PINNACLE ALTRX (98)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295016038), received between Jul 9, 2013 and Aug 15, 2025 — classified as 6 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 Dislocated3
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
- Naturally Worn1
Patient problems
- Joint Dislocation3
- No Code Available3
- Pain2
- Ambulation or Postural Difficulties1
- Insufficient Information1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryAug 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT THE PATIENT HAD DISLOCATION AND WAS IMPLANTED ABOUT TEN YEARS AGO, THE EXACT DATE IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SIDE.
Patient problems: Joint Dislocation
MAUDE report 22819772 ↗InjuryAug 17, 2023Naturally Worn; Naturally Worn
CLINICAL ADVERSE EVENT RECEIVED FOR REVISION DUE TO POLY WEAR. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2002. DATE OF REVISION: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (LEFT HIP). TREATMENT: REVISION; HEAD AND LINER WERE REVISED.
Patient problems: Insufficient Information
MAUDE report 17563672 ↗InjuryJul 11, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS DISLOCATING, SO THE SURGEON REMOVED DEPUY CUP, LINER AND HEAD AND REPLACED WITH A COMPETITOR'S CUP TO HELP STABILITY AND WENT WITH A LONGER 28 HEAD. DOI: (B)(6) 2017, DOR: (B)(6) 2019, LEFT HIP.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 8780705 ↗InjuryMay 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S CHIEF COMPLAINT WAS PAIN AND A DRAINING WOUND. THE SURGEON WENT IN AND FOUND THE COMPONENTS WELL POSITIONED AND SOLIDLY FIXED. AN I&D WITH INSERT AND HEAD SWAP WAS PREFORMED. THE ACET SHELL AND STEM WAS RETAINED. DOI: (B)(6) 2019. DOR: (B)(6) 2019; LEFT HIP.
Patient problems: No Code Available; Pain
MAUDE report 8631526 ↗InjurySep 14, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated
DER STATES THAT THE PATIENT BENT DOWN WHILE SITTING ON COMMODE AND TWISTED AROUND TO PICK UP OBJECT ON FLOOR AND FELT A POP IN HER LEFT HIP. IT WAS ALSO REPORTED THAT THERE WAS A CLOSED REDUCTION ON (B)(6) 2017 WHICH DISLOCATED AGAIN.
Patient problems: Joint Dislocation
MAUDE report 6866060 ↗InjuryJul 9, 2013Insufficient Device Problem Information
LITIGATION ALLEGES PAIN AND DIFFICULTY AMBULATING.
Patient problems: Ambulation or Postural Difficulties; No Code Available; Pain
MAUDE report 3214271 ↗
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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