PINNACLE ALTRX 1221-36-056Recalls & reported problems

Summary

The FDA's MAUDE database contains 257 adverse event reports that list this exact device (DI 10603295016342), received between Jun 29, 2017 and Sep 18, 2026 — classified as 248 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (91 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 257 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Device Dislodged or Dislocated

  Patient problems: Joint Dislocation

  MAUDE report 50823404 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was revised due to prostalac placement for infection. There was a removal of all implants.DOI: (b)(6) 2024.DOR: (b)(6) 2026.Affected side: Left.

  Patient problems: Unspecified Infection

  MAUDE report 50530844 ↗
• InjuryJun 16, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DISLOCATED HIP FOLLOWING A FALL AFTER AATHA. REVISED HEAD AND LINER. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 25522197 ↗
• InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 25471366 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WASH OUT WITH HEAD AND LINER EXCHANGE. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 25457960 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD POSSIBLE LOOSENING, HEAD/LINER WAS EXCHANGED. DOI: (B)(6) 2022. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 24871914 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD BONE LOSS ON REVISION. SURGEON REVISED HEAD AND LINER VS FEMORAL REVISION. DOI-UNKNOWN. DOR- (B)(6) 2026. AFFECTED SIDE-LEFT HIP.

  Patient problems: Bone Notching

  MAUDE report 24533767 ↗
• MalfunctionFeb 13, 2026Difficult to Insert

  IT WAS REPORTED THAT THE ALTRX NEUT 36IDX56OD WAS WASTED DUE TO AN IMPLANT DEFECT. THE LINER DID NOT LOCK INTO PLACE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. DOI: UNKNOWN DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24335400 ↗
• InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A LEG LENGTH DISCREPANCY, LINER AND HEAD EXCHANGE WAS PERFORMED. DOI, (B)(6) 2024. DOR, (B)(6) 2025. AFFECTED SIDE, LEFT HIP.

  Patient problems: Physical Asymmetry

  MAUDE report 23887726 ↗
• MalfunctionDec 18, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT 56 LINER DID NOT SEAT PROPERLY IN ACETABULAR SHELL. IT WAS NOTED THAT NOTHING WAS INTERFERING WITH THE LINER BEING IMPLANTED IN THE SHELL SUCH AS SOFT TISSUE. AFFECTED SIDE-LEFT HIP. NO ALLEGATION AGAINST THE UNKNOWN CUP. ANOTHER LINER OF THE SAME SIZE AND STYLE WAS USED AND IT IMPACTED INTO THE CUP WITH ON INCIDENCE. THERE WAS NO PATIENT CONSEQUENCE RESULTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23846213 ↗
• InjuryDec 18, 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 PAIN. DOI: (B)(6) 2020. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 23845304 ↗
• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 23680372 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 23547849 ↗
• InjuryOct 31, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO OSTEOMYELITIS AND POLY WEAR. 36 NEUTRAL LINER WAS REMOVED. SURGEON WENT BACK IN WITH 40 +4 10° LINER FOR A 56 CUP; 36 +3 HEAD WAS REMOVED. TRIAL REDUCTION PREFORMED WITH 40 +3 WAS UNSTABLE SO SURGEON WENT WITH A 40 +6. HIP WAS REDUCED, STABILITY WAS CONFIRMED, CLOSING BEGAN. WAS NO DELAYS OR ADVERSE EVENTS THAT TOOK PLACE. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23436657 ↗
• InjuryOct 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. LINER AND HEAD WERE REMOVED AND REPLACED WITH PINNACLE DUAL MOBILITY CONSTRUCT. SCREW WAS ALSO REMOVED. ALL IMPLANTS WERE INTACT. DOI: (B)(6) 2018. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23426574 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL DUE TO INFECTION. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23366996 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTS WERE REMOVED DUE TO INFECTION. STAGE 1 REVISION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23357977 ↗
• InjuryAug 15, 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 PAIN. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 22818949 ↗
• 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 INFECTED. THE SURGEON DID A WASHOUT AND A HEAD LINER SWAP. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22792234 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. ALL AVAILABLE INFORMATION HAS BEEN FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 22649447 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED AND UNDERWENT AN INFECTED HIP WASHOUT WITH ACETABULAR LINER AND FEMORAL HEAD SWAP. DOI: (B)(6) 2025 DOR: (B)(6) 2025 AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22648898 ↗
• InjuryJul 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR DISLOCATED RIGHT HIP. NO SURGICAL DELAY. REPOSITIONED CUP. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22470850 ↗
• InjuryJul 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED HIP. DOI: UNKNOWN . DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22464143 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH LINER EXCHANGED DUE TO SUSPECTED INFECTION. DOI: (B)(6) 2023 DOR: (B)(6) 2025 AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22413134 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RETURNED TO SURGERY FOR INFECTED LEFT HIP. THE WOUND WAS DEBRIDED AND THE HEAD AND LINER WERE REMOVED. FOLLOWING THE WASHOUT, TEMPORARY OFF THE SHELF IMPLANTS WERE TEMPORARILY IMPLANTED TO ALLOW FOR A TEMPORARY WOUND CLOSURE WHILE THE ENTIRE SURGICAL FIELD WAS TORN DOWN AND REPLACED WITH AN ALL NEW STERILE SET-UP. A 36 HEAD AND LINER WERE PLACED. THERE ARE NO PRODUCT FAILURE OR PATIENT HARM ALLEGATIONS ATTRIBUTED TO THESE PRODUCTS--THEY WERE PLACED MERELY AS A CONSERVATIVE JOINT SPACER WHILE THE SURGICAL PROCEDURE 2ND STAGE WAS PREPARED. AFTER RE-OPENING THE SURGICAL WOUND, THE TEMPORARY 36 HEAD AND LINER WERE REMOVED AND DEFINITIVE PERMANENT IMPLANTS, A 40 HEAD AND LINER, WERE IMPLANTED AND PATIENT SUCCESSFULLY CLOSED. THERE WERE NO COMPLICATIONS. THERE WERE NO DELAYS. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22327027 ↗