PINNACLE ALTRX 1221-28-144Recalls & reported problems
Depuy Orthopaedics, Inc. · PINNACLE HIP SOLUTIONS ALTRX POLYETHYLENE ACETABULAR LINER +4 10 DEGREE 28mm ID 44mm OD · Class 2 · Implant
All models of PINNACLE ALTRX (98)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295015987), received between Jan 31, 2018 and Sep 24, 2026 — classified as 12 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 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 Dislocated9
- Fracture2
- Naturally Worn2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Joint Dislocation7
- Pain3
- No Code Available2
- Insufficient Information1
- Joint Laxity1
- Not Applicable1
- Physical Asymmetry1
- Unspecified Infection1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
Patient was revised due to infection.DOI: Unknown.DOR: (b)(6) 2026.Affected Side: Unknown.
Patient problems: Unspecified Infection
MAUDE report 50889086 ↗InjuryOct 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO CHRONIC DISLOCATIONS. DOI: (B)(6) 2020, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 23318554 ↗InjuryMar 24, 2025Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated
IT WAS REPORTED THE PATIENT UNDERWENT RIGHT TOTAL HIP REPLACEMENT IN 2023. THE PATIENT EXPERIENCED HIP PAIN, LIMPING AFTER SQUATTING AND TURNING IN (B)(6) 2025. THE PATIENT RETURNED TO HOSPITAL FOR EXAMINATION, X-RAY AND CT SHOWED DEVICE DISLOCATION. THE PATIENT UNDERWENT TOTAL HIP REVISION SURGERY. AFTER REMOVAL, IT WAS FOUND THAT THE LINER WAS BROKEN AND THE CERAMIC HEAD IN CONTACT WITH IT WAS PARTIALLY BLACK.
Patient problems: Joint Dislocation; Pain; Physical Asymmetry
MAUDE report 21676848 ↗InjuryDec 7, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT CHRONICALLY DISLOCATED AND ELECTED TO CONVERT TO A DIFFERENT VENDOR CUP. DEPUY CUP, LINER AND HEAD WAS REMOVED. (B)(6). AFFECTED SIDE : LEFT HIP
Patient problems: Joint Dislocation
MAUDE report 18283274 ↗InjuryFeb 23, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO DISLOCATION. THERE WAS NO SURGICAL DELAY. DOI- (B)(6) 2022. DOR- (B)(6) 2023. AFFECTED SIDE- RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 16428050 ↗InjuryJan 9, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
REVISION COMPLETED DUE TO RECURRENT DISLOCATIONS. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 16124619 ↗InjuryJun 7, 2022Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated
PATIENT ACCOUNT OF EXPERIENCE: I FELT AN IMBALANCE WITH PAIN IN THE LEG WHERE I WAS PLACED WITH THE PROSTHESIS, AFTER THE PAIN A SQUEAK HAS INCREASED, I WENT TO CONSULT WITH THE TREATING DOCTOR AND HIS DIAGNOSIS IS THAT THE PROSTHESIS HAD A BREAK IN THE POLYETHYLENE PART, (THAT THE PIECE CAME OUT WRONG). HOSPITAL REPORT: HEREBY INFORM YOU THAT THE PATIENT UNDERWENT SURGICAL TREATMENT; THE SURGERY WAS LEFT HIP TOTAL ARTHROPLASTY AND WAS PERFORMED WITHOUT COMPLICATIONS. THE PROSTHESIS THAT WAS PLACED IN THIS PROCEDURE WAS JOHNSON'S PROSTHESIS, SUMMIT STEM PINACLE ACETABULUM, AND CORAIL.
Patient problems: Joint Laxity; Pain
MAUDE report 14621362 ↗InjuryOct 5, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
HIP REVISION SIZE 44 PINNACLE MULTI HOLE CUP WITH LINER DISASSOCIATION. DOI: UNKNOWN. DOR: (B)(6) 2021. UNKNOWN SIDE.
Patient problems: Insufficient Information
MAUDE report 12577712 ↗InjuryAug 3, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED DUE TO DISLOCATION. DOI: UNKNOWN - DOR: (B)(6) 2021 (RIGHT HIP).
Patient problems: Joint Dislocation
MAUDE report 12269102 ↗InjurySep 1, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2020. THE PATIENT ENDED UP HAVING A DISLOCATION AND A CLOSED REDUCTION WAS PERFORMED. UNFORTUNATELY, THE PATIENT HAD ANOTHER DISLOCATION, THE SECOND TIME, AND WAS UNABLE TO REDUCE THE HIP. THE SURGEON DECIDED TO REVISE THE PATIENT'S ACETABULAR COMPONENT THOUGH HE FELT THAT THE POSITIONING OF THE CUP WAS APPROPRIATE. HE ALSO FELT THAT MAYBE THE PATIENT WAS POSSIBLY DISLOCATING DUE TO THE SMALL SIZE OF THE COMPONENTS. A 44 MM CUP WAS REMOVED, THE BONE WAS REAMED UP TO 47 AND A 47 MM BIMENTUM CUP WAS IMPLANTED. THIS ALLOWED THEM TO INCREASE THE SIZE OF THE FEMORAL HEAD WHICH HELPED WITH THE PATIENT'S STABILITY. A 28 MM +1.5 TS CERAMIC HEAD WAS USED INSIDE THE BIMENTUM POLY AND RAN THROUGH A FINAL RANGE OF MOTION. IT WAS FOUND TO BE SATISFACTORY AND THE PATIENT WAS CLOSED UP. NO SURGICAL DELAY NOTED. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT HIP.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 10476141 ↗InjuryMar 21, 2018Naturally Worn; Naturally Worn
DER STATES POLYETHYLENE WEAR AND INSTABILITY. CONVERTED TO CONSTRAINED LINER. DOI: (B)(6) 2016 ; DOR: (B)(6) 2018 (LEFT HIP).
Patient problems: No Code Available
MAUDE report 7356830 ↗InjuryJan 31, 2018Naturally Worn; Naturally Worn
DER STATES THAT THE PATIENT HAD A LEFT TOTAL HIP DONE IN (B)(6) IN (B)(6) 2013. THIS WAS WITH A CORAIL STEM AND PINNACLE CUP. DEVELOPED PAIN A YEAR AGO AND WAS BROUGHT IN FOR REVISION. THE 44 MM LINER WAS DISASSOCIATED WITH THE CUP. IT LOOKED LIKE A +4 10 DEGREE LINER BUT THE LIP OF THE LINER WAS IN PIECES AND NO NUMBERS COULD BE SEEN. THE 28 MM +1.5 CERAMIC HEAD SHOWED WEAR ON THE HEAD. A NEW 44 MM +4 10 DEFEEE LINER WAS IMPLANTED WITH A TS CERAMIC 28 MM +5 HEAD. DOI: (B)(6) 2013; DOR: (B)(6) 2018; LEFT HIP.
Patient problems: Not Applicable; Pain
MAUDE report 7230299 ↗
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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