PINNACLE ALTRX 1221-32-048Recalls & reported problems

Summary

The FDA's MAUDE database contains 260 adverse event reports that list this exact device (DI 10603295016090), received between Jul 20, 2017 and Sep 24, 2026 — classified as 252 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (128 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 260 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was revised due to instability.DOI: Unknown. DOR: (b)(6) 2026.Affected side: Unknown hip.

  Patient problems: Joint Laxity

  MAUDE report 50888516 ↗
• InjurySep 24, 2026Device Dislodged or Dislocated; Naturally Worn

  It was reported that ALTRX NEUT 32IDX48OD was associated with liner disassociation identified on X-ray during a planned revision arthroplasty. Intra-operatively, the liner was described as worn and warped, and the ceramic femoral head exhibited substantial wear. The acetabular cup appeared intact, and the screw was flush. Patient harm was reported, and revision surgery was required; as a result, the head and liner were revised, and a new lipped liner and TS head were implanted. The implant products involved were explanted; the ALTRX NEUT 32IDX48OD and UNK Hip Femoral Head Ceramic were discarded, and the UNK Hip Acetabular Cup Pinnacle was retained by the customer.

  Patient problems: Insufficient Information

  MAUDE report 50884247 ↗
• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was revised due to instability.Affected side-Right Hip.

  Patient problems: Joint Laxity

  MAUDE report 50495535 ↗
• InjuryJul 29, 2026Fracture; Device Dislodged or Dislocated

  It was reported that head and liner exchange was performed due to disassociation of liner from the shell. Liner was no longer in shell casing metal transfer to the ceramic head from the shell, ARDs we sheared off from the liner.DOI: (b)(6) 2023.DOR: (b)(6) 2026.Affected Side: Unknown.

  Patient problems: Insufficient Information

  MAUDE report 50072915 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  Patient was revised due to infection.DOI: ON (b)(6) 2022,DOR: ON (b)(6) 2026,Affected Side: Right Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50009484 ↗
• InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD SHORT LEG LENGTH DISCREPANCY AND SURGEON WANTED TO REMOVE HEAD/LINER TO GIVE PATIENT ADDITIONAL LEG LENGTH. AFFECTED SIDE: LEFT HIP.

  Patient problems: Physical Asymmetry

  MAUDE report 25472250 ↗
• InjuryMay 4, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD CHRONIC DISLOCATION. CONVERTED TO DJO AND REPLACED LINER. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 25067675 ↗
• InjuryApr 7, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD HIP DONE ORIGINALLY ON (B)(6) 2020. PATIENT SUFFERED A DISLOCATION. DR. FELT THE PATIENTS CUP POSITION MAY BE THE CAUSE FOR DISLOCATION. THEY OPTED TO REVISE THE CUP TO A COMPETITOR ACETABULAR COMPONENT. TRIAL REDUCTION WAS PERFORMED WITH A NEW FEMORAL HEAD TRIAL AND THE HIP WAS FOUND TO BE STABLE. NEW TS CERAMIC FEMORAL HEAD WAS OPENED AND IMPLANTED. STABILITY OF THE HIP WAS CONFIRMED AND THE CLOSING PROCESS BEGAN. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. ACTIVITY LEVEL - YES, DOI: (B)(6) 2020, DOR: UNKNOWN AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24805112 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. DOI: ON (B)(6) 2024, DOR: ON (B)(6) 2026, AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 24800553 ↗
• InjuryFeb 24, 2026Fracture; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING: PATIENT CALLED ON (B)(6) 2026, STATING THAT THERE WAS NO HISTORY OF FALLS BUT THE HIP FELT UNSTABLE AND LIKE IT WAS GOING TO "POP." DURING THE REVISION, THE LINER WAS JAGGED AND BROKEN OFF. THE FEMORAL HEAD WAS BLACK AND "SCRAPED UP." THE SURGEON STATED THE HEAD RUBBING ON THE CUP WAS THE CAUSE OF THE SQUEAKING. DOI: 2018. DOR: 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 24431173 ↗
• InjuryFeb 6, 2026Naturally Worn

  IT WAS REPORTED THAT THE PATIENT HAD HER HIP REPLACED APPROXIMATELY 15 YEARS AGO AND DID WELL UNTIL RECENTLY THE PATIENT BEGAN TO FEEL UNSTABLE. THE ORIGINAL DOS, SURGEON, AND PLACE OF SURGERY IS UNKNOWN. THE PATIENT CAME IN AND SEEN THE SURGEON WHERE THE SURGEON DETERMINED THAT POLYETHYLENE WEAR WAS THE CAUSE OF THE INSTABILITY SENSATION THE PATIENT WAS FEELING. A REVISION SURGERY WAS DONE WHERE THE SURGEON REPLACED THE HIP BALL AND LINER. THE LOT NUMBER INFORMATION WAS UNABLE TO RETRIEVED BECAUSE OF THE WEAR ON THE IMPLANTS. THE SROM STEM AND PINNACLE CUP WERE LEFT IN VITRO AND WERE WELL FIXED. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 24279913 ↗
• InjuryJan 23, 2026Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ALTRX NEUT 32IDX48OD, UNKNOWN HIP FEMORAL HEAD, AND UNKNOWN HIP ACETABULAR CUP WERE INVOLVED IN A REPORTED EVENT. THE PATIENT EXPERIENCED PAIN DUE TO A LOOSE OR BROKEN LINER, NECESSITATING A HIP REVISION PROCEDURE IN WHICH THE LINER AND HEAD WERE REMOVED AND REPLACED.

  Patient problems: Pain

  MAUDE report 24159783 ↗
• InjuryJan 12, 2026Fracture

  IT WAS REPORTED THAT THE RIM OF THE LINER BROKE OFF. THE PIECE THAT BROKE OFF WAS ABOUT AN INCH AND A HALF LONG. THE SCREW WAS ALSO REMOVED AS IT WAS NOT SERVING A PURPOSE ANY LONGER. REPLACED IT WITH THE SAME LINER. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 24037017 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION OCCURRED ON (B)(6) 2025 DUE TO INFECTION. DOI: UNKNOWN, DOR: ON (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23744400 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT NEEDED MORE STABILITY, OPTED FOR DUAL MOBILITY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 23349736 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LINER EXCHANGE TO PDM. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Joint Laxity

  MAUDE report 23003902 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PATIENT HAD HER HIP REPLACED RECENTLY AND COME INTO THE ER WITH AN INFECTION. THE SURGEON EXPLANTED ALL OF HER COMPONENTS AND DID A THOROUGH I&D AND REIMPLANTED A NEW STEM, CUP, DUAL MOBILITY HEAD AND LINER. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22980523 ↗
• InjuryAug 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING POSTERIOR DISLOCATION, WHICH REQUIRED A REVISION OF LINER AND HEAD.

  Patient problems: Joint Dislocation

  MAUDE report 22917238 ↗
• InjuryAug 13, 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 INSTABILITY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 22797999 ↗
• InjuryAug 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22708111 ↗
• MalfunctionJul 25, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT 32X48 LINER DID NOT SEAT PROPERLY IN THE 48 CUP USED. THE SURGEON CHANGED OUT THE LINERS AND THE NEW ONE SAT INSTANTLY. DOE: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22608817 ↗
• InjuryJul 14, 2025Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT SURGEON HAD A PATIENT PRESENTED WITH A DISASSOCIATED PINNACLE ALTRX LINER REQUIRING REVISION. THERE WAS LOOSENING OF 48X32 N ALTRX LINER AT NON-CEMENTED INTERFACE. CEMENT MANUFACTURE WAS UNKNOWN. THE FEMORAL HEAD WAS DISPLACED SUPERIOR AND RUBBING THE SUPERIOR RIM OF THE CUP. AFTER EXPLANTING THE FEMORAL HEAD AND REMAINING LINER, THOROUGH WASHOUT/DEBRIDEMENT, AND CUP/STEM STABILITY/FIXATION CHECKED, A DM CONSTRUCT WAS DETERMINED TO BEST CORRECT POSSIBLE CAUSATIONS. HIP WAS REDUCED WITH A 48X41 DM LINER, 41X22.225 HEAD LINER, AND 22.225 METAL HEAD. STABILITY WAS SATISFACTORY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 22495941 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. I&D HEAD LINER WAS EXCHANGED. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22373137 ↗
• InjuryMay 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT DISLOCATED AND NEED DM. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22088872 ↗
• InjuryMay 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S IMPLANT WAS DISLOCATING. REVISED TO +4 10° LINER AND 32+9 HEAD. NO ADDITIONAL INFORMATION WAS AVAILABLE. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED AREA: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22072497 ↗