PINNACLE ALTRX 1221-32-448Recalls & reported problems

Summary

The FDA's MAUDE database contains 134 adverse event reports that list this exact device (DI 10603295016274), received between Jul 19, 2017 and Sep 16, 2026 — classified as 132 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (77 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 134 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Device Dislodged or Dislocated

  It was reported that patient poly was disassociated in cup.Affected side- Left Hip.

  Patient problems: Insufficient Information

  MAUDE report 50787044 ↗
• InjurySep 14, 2026Adverse 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 50754541 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LEG LENGTH ADJUSTMENT. AFFECTED SIDE: LEFT.

  Patient problems: Physical Asymmetry

  MAUDE report 25395610 ↗
• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS HAVING DISCOMFORT AND IMPINGEMENT ISSUES, SO THE DOCTOR REVISED. NO KNOWN INFECTION PRESENT. NO DELAY IN SURGERY. DOI: ON (B)(6) 2017, DOR: ON (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Discomfort; Joint Laxity

  MAUDE report 25382320 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS INFECTED. HEADBALL POLY EXCHANGE WAS PERFORMED. THERE WAS NO DELAY. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25043550 ↗
• InjuryFeb 20, 2026Naturally Worn

  IT WAS REPORTED THAT THE PATIENT RETURNED FOR ANOTHER COMPONENT EXCHANGE. PATIENT HAD EXTENSIVE HEAD AND POLY WEAR A SECOND TIME. THE DOCTOR EXPLANTED CUP TO REPOSITION. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Insufficient Information

  MAUDE report 24399373 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: 1. CAN YOU PLEASE PROVIDE THE LOT NUMBER OF THE "PINN MULTIHOLE W/GRIPTION 48MM"? - UNFORTUNATELY THE LOT NUMBER WASN'T LEGIBLE. 2. WHAT IS THE AFFECTED SIDE INVOLVED IN THIS EVENT? LEFT OR RIGHT? -LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 24144503 ↗
• InjuryNov 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD TRAUMATIC FALL AND DISLOCATED MULTIPLE TIMES. DOCTORS WENT TO DM. NO ADDITION INFORMATION IS AVAILABLE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 23463727 ↗
• InjuryOct 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT REVISION WAS PERFORMED BECAUSE THE PATIENT WAS DISLOCATING. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23393636 ↗
• InjuryOct 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: C. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? NO. D. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? NOT IN THE OPINION OF THE SURGEON. E. WERE ANY COMPONENTS UNDERSIZED ON THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? NOT IN THE OPINION OF THE SURGEON. F. WAS THE FEMUR OR TIBIA EXCESSIVELY RESECTED/JOINT LINE RAISED DURING THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? WHAT? THIS WAS A REVISION OF A THA... THIS HAS NOTHING TODO WITH THE KNEE JOINT LINE. NO THERE WAS NO OVER-RESECTION.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 23316157 ↗
• InjuryAug 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS BEING REVISED BECAUSE SHE DISLOCATED TWICE. A 48MM 32 PINNACLE +4 NEUTRAL LINER AND 32 +1 CERAMIC HEAD WERE REMOVED. DOCTOR IMPLANTED A PINNACLE CONSTRAINED 48-28 +4 NEUTRAL LINER AND A REVISION 28 +1.5 CERAMIC HEAD. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22817574 ↗
• InjuryJul 14, 2025Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  THE PATIENT HAD A HEAD AND LINER EXCHANGE WITH CUP REMOVAL. THIS WAS THE SECOND HEAD AND LINER EXCHANGE, THE LINER WAS DISSOCIATED FROM THE CUP AND DAMAGED. CUP REMOVAL WAS DONE TO USE MORE SCREWS AND DUAL MOBILITY. THE ORIGINAL CUP IMPLANT DATE, REFERENCE NUMBER AND LOT ARE UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 22500475 ↗
• InjuryJul 1, 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 LEFT HIP. NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22375892 ↗
• InjuryJun 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HIP REVISION. SURGEON TOOK OUT THE 48 POROCOAT CUP/LINER AND 32 +5 HEAD AND REPLACED WITH A 54 GRIPTION MULTIHOLE, 54 DUAL MOBILITY LINER WITH A 47/28 OUTER/INNER HEAD. THE OTHER CUP WAS DISLOCATING AND THERE WAS NON-CEMENTED LOOSENING OF THE CUP. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 22187307 ↗
• InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATENT HAD HIP INSTABILITY AND WAS CONVERTED TO A DIAL MOBILITY CONSTRUCT. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 22186752 ↗
• InjuryMay 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE HEAD BALL AND POLYETHYLENE EXCHANGE DUE TO DISLOCATION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22107872 ↗
• InjuryMay 22, 2025Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE ORIGINAL LINER DISASSOCIATED FROM THE CUP. THE LINER WAS BROKE AND ALL PIECES REMOVED. NO DAMAGE TO CUP SO A NEW LINER AND HEAD WAS PUT IN. THE DEVICE WAS IMPLANTED AROUND 10 YEARS AGO AT SAME FACILITY BY THE SAME SURGEON. THERE WAS NO CASE DELAY, AND ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 22070390 ↗
• InjuryApr 23, 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 INFECTION. SURGEON REMOVED ALL IMPLANTS AND REPLACED WITH TEMPORARY SPACER. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21892068 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT HIP REMOVAL OF IMPLANTS DUE TO INFECTION. DOI: UNKNOWN. DOR:(B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21853772 ↗
• InjuryFeb 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS WAS THE 2ND LINER DISASSOCIATION. THE CUP WAS DAMAGED. SURGEON EXPLANTED THE CUP, HEAD, AND LINER. THE CUP WAS 48 SECTOR CUP. THE PRIMARY CASE WAS DONE ELSEWHERE SO NO INFO ON CUP REF OR LOT NUMBERS. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Insufficient Information

  MAUDE report 21344176 ↗
• InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HEAD AND LINER WERE EXCHANGED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21307458 ↗
• InjuryJan 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON EXPLANTED POLY, HEAD, SCREWS. THE PATIENT WAS HAVING GROIN PAIN SO THE DOCTOR ELECTED TO REMOVE THE SCREWS IN THE CUP. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 21197774 ↗
• InjuryOct 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT CAME IN AFTER DISLOCATING TWICE IN A WEEK. DR DECIDED IT BEST TO REMOVED THE CUP, LINER, HEAD AND STEM TO CHANGE THE ORIENTATION OF THE IMPLANT TO BE MORE STABLE. HE PLACED A NEW 16X11 +6 STEM AND A 28 +6 HEAD INTO A ZIMMER CUP/DUAL MOBILITY. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. NO MORE PATIENT INFORMATION IS AVAILABLE AT THIS TIME. DOI- UNKNOWN. DOR- (B)(6) 2024. AFFECTED SIDE- LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 20453055 ↗
• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE REMOVAL OF PINNACLE GRIPTION 48 MM CUP,32-48 +4 NEUTRAL LINER, APEX HOLE ELIMINATOR, PINNACLE SCREW 6.5 30MM, AND ARTICUL/EZE FEMORAL HEAD 32+1 PERFORMED DUE TO INSTABILITY. THERE WAS NO SURGICAL DELAY IN THE CASE, AND NO INFORMATION WAS PROVIDED OF WHEN IMPLANTATION OCCURRED. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: UNKNOWN HIP SIDE.

  Patient problems: Joint Laxity

  MAUDE report 20344866 ↗
• InjuryAug 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT KEPT DISLOCATING. THE HEAD AND LINER REPLACED WITH A CONSTRAINED LINER AND NEW HEAD. DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 19960222 ↗