PINNACLE ALTRX 1221-36-152Recalls & reported problems

Summary

The FDA's MAUDE database contains 316 adverse event reports that list this exact device (DI 10603295016403), received between Feb 2, 2016 and Sep 10, 2026 — classified as 1 death, 312 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (177 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 316 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Fracture

  It was reported a THA revision was performed for a disassociated liner after the patient had fell down while playing pickle ball. The patient was about 3 year post-op on the day of the revision. After exposure and dislocation of the hip, and removal of the femoral head, the surgeon inspected the liner. The liner (Altrx 36/52 +4 / 10 degrees) was not really disassociated but rather had broken into a few pieces. The elevated portion of the liner (the 10 degree lip) had broken off, as well as some of the ARDs.The stem in situ is a Corail KLA size 13. The femoral head had been rubbing directly against the cup for some time, so there was some intra-articular debris. The surgeon opted to remove the cup and upsize to a size 54. He used an Emphasys multi-hole and elevated rim liner. He then used a TS Delta ceramic head size 40+5. The Corail stem was well fixed and remained in situ. The post x-rays were satisfactory and the patient is in good condition.

  Patient problems: Fall

  MAUDE report 50713912 ↗
• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient had infected hip. Washout/I&D was performed. Head and poly were swapped.Affected side- Left Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50452491 ↗
• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Patient had infected hip. Washout/I&D was performed. Head and poly were swapped.Affected side-Left.

  Patient problems: Unspecified Infection

  MAUDE report 50452336 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  Thayer School of Engineering at Dartmouth first report of retrievals for Statement of Work 10 for Q2 of 2026. Darthmouth is the research location, and not the facility of placement.A DePuy Synthes Implant was revised and reviewed for analysisReason for revision: Revision due to instabilty/loose.

  Patient problems: Joint Laxity

  MAUDE report 50180650 ↗
• InjuryJul 30, 2026Device Dislodged or Dislocated

  It was reported that the patient dislocated. The cup became unstable post dislocation and had to be revised.DOI:(b)(6) 2026,DOR: (b)(6) 2026,Affected side: Left Hip.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 50086263 ↗
• InjuryJul 27, 2026Device Dislodged or Dislocated

  It was reported that a revision THA was performed due to dislocation.DOI: (b)(6)2026.DOR: (b)(6)2026.Affected side-Left hip.

  Patient problems: Joint Dislocation

  MAUDE report 50022265 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL WASH OUT. DOI: UNKNOWN, DOR: 2026, AFFECTED SIDE-RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 25035829 ↗
• InjuryApr 29, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY AND DISLOCATION. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 25027048 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS INFECTED. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24767475 ↗
• InjuryFeb 19, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD CHRONIC DISLOCATION; CONVERTED TO CONSTR LINER. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24387882 ↗
• InjuryFeb 3, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT COMES BACK IN TODAY FOR A HEAD AND LINER REVISION DUE TO CHRONIC DISLOCATION. THE SURGEON REMOVED THE LINER AND HEAD THEN PLACED A CONSTRAINED LINER WITH A 32 DELTA TS HEAD. NO MORE PATIENT INFORMATION WAS AVAILABLE AT THIS TIME. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24245354 ↗
• InjuryJan 14, 2026Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT POLY LINER WAS CRACKED AND DISASSOCIATED. NEW POLY AND HEAD WERE IMPLANTED. DOI- UNKNOWN. DOR- (B)(6) 2025. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 24068724 ↗
• InjuryJan 5, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT FELL AND BROKE HER HIP IN JUNE. A TOTAL HIP WAS DONE. PATIENT HAD A LINER AND HEAD REVISION ON (B)(6) 2025 BECAUSE PATIENT DISLOCATED MULTIPLE TIMES. SOMEWHERE BETWEEN OCTOBER 26, 2025 AND DECEMBER 16, 2025 THE PATIENT DISLOCATED AGAIN. PATIENT WAS NOT AT THE HOSPITAL FOR HIP PAIN BUT THEY TOOK AN X RAY ANYWAY AND FOUND IT TO BE DISLOCATED. PATIENT ALSO HAD WHAT WAS BELIEVED TO BE A SINUS TRACK ON HER SCAR SO THE DOCTOR DECIDED TO DO AN EXPLANT WITH GIRDLE STONE. DOI: (B)(6), 2025 DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT HIP. (B)(4) CAPTURES THE FIRST DISLOCATION REVISION AND (B)(4) CAPTURES THE SECOND DISLOCATION AND THE GIRDLE STONE PROCEDURE.

  Patient problems: Joint Dislocation

  MAUDE report 23967982 ↗
• InjuryDec 31, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  (B)(6) SCHOOL OF ENGINEERING AT (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK FOR Q4 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: "REVISION FOR DISLOCATION AND INSTABILITY. THE NON-ARTICULAR SURFACE OF THE POLYETHYLENE ACETABULAR LINER SHOWS MINOR YELLOWING".

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 23934193 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 23925495 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HIP HAD DISLOCATED SEVERAL TIMES. THE DOCTOR DECIDED TO TAKE THEM BACK TO SURGERY AND REPLACE THE LINER AND HEAD WITH A CAPTURED LINER. SURGEON SAID THAT NOTHING WAS WRONG WITH OUR COMPONENTS AND JUST THOUGHT IT WAS A PATIENT COMPLIANCE ISSUE WITH THE DISLOCATIONS. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23707978 ↗
• InjuryDec 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS DISLOCATED AND NEEDS MORE CONSTRAINT. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23694133 ↗
• InjuryNov 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE HIP WAS DISLOCATING. IT CHARGE TO CONSTRAINED HEAD AND LINER. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23555023 ↗
• InjuryNov 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. REPLACED WITH CONSTRAINED LINER. DOI (B)(6) 2020, DOR (B)(6) 2025, AFFECTED SIDE-UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 23547355 ↗
• InjuryOct 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT SUFFERS FROM DISLOCATION. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23382245 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 23075879 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED HIP. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23057545 ↗
• InjurySep 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISLOCATION AND NEED MORE CONSTRAINING POLY. REVISION WAS PERFORMED. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23037584 ↗
• InjuryAug 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HEAD AND LINER EXCHANGE DUE TO DISLOCATED HIP. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22783821 ↗
• InjuryAug 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT DISLOCATED MULTIPLE TIMES. SURGEON WANTED TO USE A CONSTRAINED LINER. THE SURGEON REMOVED THE HEAD, LINER, HOLE ELIMINATOR, AND CUP. THE SURGEON REAMED UP TO 53MM REAMER. THE SURGEON IMPLANTED NEW 54 CUP AND PLACED NEW CONSTRAINED POLY IN NEW CUP TO ENSURE THIS NON-COMPLIANT PATIENT WOULD HAVE THE BEST CHANCES OF NOT DISLOCATING IN THE FUTURE. DOI: (B)(6) 2019. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22750948 ↗