PINNACLE ALTRX 1221-36-156Recalls & reported problems

Summary

The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 10603295016427), received between Jan 9, 2017 and Sep 18, 2026 — classified as 90 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (53 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 92 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50824965 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the head liner was explanted due to infection. No delays in case or harm to the patient. There were no complaints from the surgeon.DOI: (b)(6)2026.DOR: (b)(6)2026.Affected Side: Unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50036291 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  . WHAT IS THE EXACT ALLEGATION OF THE REPORTED PRODUCT? -THERE WAS NO ALLEGATION. PRODUCTS WERE REMOVED TO CONDUCT AN I&D DUE TO SUSPECTED INFECTIONS.

  Patient problems: Unspecified Infection

  MAUDE report 24236441 ↗
• InjuryJan 30, 2026Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24221643 ↗
• InjuryJan 14, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DISLOCATION AND FRACTURE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24069115 ↗
• InjuryAug 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD EXCHANGED POLY AND HEAD AFTER WASHING OUT THE JOINT FOR INFECTION. AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 22814760 ↗
• InjuryJun 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION. THE HEAD AND LINER WERE EXCHANGED. THERE WAS NO ALLEGATION AGAINST THE CUP. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22358834 ↗
• InjuryMay 7, 2025Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY. PRIMARY COMPLAINT IS PAIN AND INSTABILITY. ELEVATED METAL ION LEVELS WERE ALSO REPORTED. THE SURGEON COULD NOT DECIDE IF THE CUP WAS ACTUALLY LOOSE OR NOT. THE CUP WAS INDETERMINATE. IT WAS NOT OBVIOUSLY LOOSE WHEN REMOVED, BUT INGROWTH WAS MINIMAL. THE LINER WAS BROKEN AND PARTIALLY DISLOCATED, BUT THE SURGEON BELIEVES THAT IT MIGHT HAVE NOT BEEN FULLY SEATED IN THE ORIGINAL SURGERY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity; Pain

  MAUDE report 21975965 ↗
• InjuryMay 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE REVISION OF A C-STEM PINNACLE WAS DONE DUE TO DISLOCATION. THE SURGEON DESCRIBED THE CUP AS TOO OPEN/STEEP WITH EXCESSIVE INCLINATION. THE LINER AND CERAMIC 36 +5 HEAD WERE REMOVED. THE CUP WAS CONVERTED TO PINNACLE DM AND A REVISION 28+8.5 CERAMIC HEAD WAS IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PRIMARY: ON (B)(6) 2025, REVISION: ON (B)(6) 2025, AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Joint Dislocation

  MAUDE report 21969776 ↗
• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON REPLACED HEAD/LINER AFTER HIP I&D TO TREAT INFECTION. THERE WAS NO DELAY AND NO COMPLAINTS. THE ITEMS ARE NOT AVAILABLE FOR RETURN. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21740267 ↗
• InjuryMar 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LINER AND HEAD WERE REVISED FOR DISLOCATION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21700152 ↗
• InjuryFeb 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. THE PATIENT WAS CONVERTED TO CONSTRAINED LINER. THE SURGICAL DELAY IS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21346064 ↗
• InjuryDec 31, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO RECURRENT DISLOCATION. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21047714 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A KNOWN INFECTION. THE PATIENT HAD IRRIGATION AND DEBRIDEMENT (I&D) WITH HEAD & LINER EXCHANGE. NO DELAYS, NO HARM DONE, NO ADVERSE CONSEQUENCES, NO BROKEN INSTRUMENTS OR IMPLANTS. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20269058 ↗
• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A POSSIBLE INFECTION. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20238589 ↗
• InjuryApr 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: INSTABILITY. AT REVISION THERE WAS FRETTING OF THE FEMORAL HEAD.

  Patient problems: Joint Laxity

  MAUDE report 19181596 ↗
• InjuryApr 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO DISLOCATION. IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. DOI: ON (B)(6) 2020, DOR: UNKNOWN, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 19116000 ↗
• InjuryMar 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO RECURRENT DISLOCATION. HEAD LINER EXCHANGE. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. NO ADDITIONAL INFORMATION. DOI (B)(6) 2014. DOR (B)(6) 2024. AFFECTED SIDE RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 18920593 ↗
• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. THE THA IMPLANTS WERE REPLACED WITH A PROSTALAC HIP. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6), 2010, DOR: (B)(6), 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18334173 ↗
• InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTED HIP, SO THE SURGEON DID AN IRRIGATION AND DEBRIDEMENT AND REMOVED THE POLYETHYLENE LINER AND HEAD BALL. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE : LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18132927 ↗
• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED FOR INSTABILITY. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 18093986 ↗
• InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THE SURGEON REMOVED HEAD AND LINER, WASHED OUT THE JOINT AND REPLACED WITH NEW HEAD AND LINER. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17844082 ↗
• InjurySep 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD SEVERAL DISLOCATIONS POST HIP REPLACEMENT. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17747077 ↗
• InjuryJul 11, 2023Fracture; Device Dislodged or Dislocated; Material Deformation; Fracture; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PRIMARY RIGHT CORAIL/PINNACLE TKR. PATIENT SUBSEQUENTLY HAS EXPERIENCED DISLOCATION OF JOINT. SURGEON SUSPECTED THE CUP WAS IN SLIGHTLY MORE ANTEVERSION THAN INTENDED. PATIENT HAS A +4/10 DEGREE LINER IN-SITU, WHICH IN ITS CURRENT ORIENTATION WAS IMPINGING ON THE NECK OF THE FEMORAL STEM, LEADING TO DISLOCATION. PROCEDURE REVISION OF ACETABULAR LINER AND HEAD CHANGE. SURGEON REMOVED EXISTING LINER, REPLACED IT WITH ANOTHER +4/10 DEGREE LINER WITH THE ORIENTATION CHANGED. UPON REMOVING THE EXISTING LINER THE SURGEON NOTED AN OBVIOUS 'DENT' IN THE LINER WHERE THE NECK HAD BEEN IMPACTING IT. DOI: (B)(6)2022. DOE: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 17297304 ↗
• InjuryMay 9, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION, HEAD & LINER EXCHANGE. DOI: UNK. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Dislocation

  MAUDE report 16897023 ↗