PINNACLE ALTRX 1221-40-456Recalls & reported problems

Summary

The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 10603295016595), received between Jun 23, 2017 and Sep 10, 2026 — classified as 1 death, 79 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (27 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 81 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Device Dislodged or Dislocated

  It was reported that the patient underwent the second revision for dislocating hip. This time they went with dual mobility with a bigger head.DOI: Unknown .DOR: (b)(6)2026.Affected side: Left hip.

  Patient problems: Joint Dislocation

  MAUDE report 50716430 ↗
• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTION DUE TO WHICH ALL THE COMPONENTS WERE EXPLANTED AND SPACER IMPLANTED. DOI- (B)(6) 2026. DOR- (B)(6) 2026. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24753352 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE PRELIMINARY DATA REPORT WAS FROM THE ORTHOPEDIC RESEARCH FOUNDATION (ORTHOINDY), WHICH INCLUDES INFORMATION COLLECTED FROM SAINT VINCENT HOSPITAL AND HEALTH CARE CENTER, AS PART OF AN ON-GOING DATA USE AGREEMENT. THIS IS THE INTERIM VERSION OF THE DATA COLLECTION TEMPLATE (DCT), WHICH INCLUDES SAFETY-RELATED INFORMATION FOR THE VA-LCP PPFX SYSTEM. DURING THE REVIEW, DEPUY SYNTHES JOINT RECONSTRUCTION PRODUCTS WERE IDENTIFIED AS INVOLVED IN SOME OF THE COMPLICATIONS. A TOTAL OF 4 COMPLICATIONS INVOLVING JOINT RECONSTRUCTION PRODUCTS HAVE BEEN REPORTED ACROSS 3 PATIENTS. ALL COMPLICATIONS REQUIRED SURGICAL INTERVENTION. SUBJECT NUMBER (B)(6), 73-YEAR-OLD FEMALE. PATIENT EXPERIENCED ADVERSE TISSUE REACTION, ALLERGY/HYPERSENSITIVITY REACTION REQUIRING TROCHANTERIC DEBRIDEMENT. DATE OF ORIGINAL SURGERY WAS ON (B)(6) 2022.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction

  MAUDE report 23525793 ↗
• InjuryAug 22, 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 IN THEIR HIP, SO THE SURGEON REVISED THE IMPLANT. NO KNOWN INFECTION WAS PRESENT. THERE WAS NO DELAY IN SURGERY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 22871451 ↗
• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THEY DID A HEAD AND LINER EXCHANGE WITH A WASH OUT. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22840762 ↗
• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT REVISION HIP SURGERY DUE TO INSTABILITY. STEM WAS NOT REVISED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 22232031 ↗
• InjuryJan 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2018. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21232061 ↗
• InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LINER AND CERAMIC HEAD REVISED DUE TO INFECTION. IDENTICAL SIZES WERE USED IN THE REVISION SURGERY. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HEAD.

  Patient problems: Unspecified Infection

  MAUDE report 20725861 ↗
• InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HEAD AND LINER WERE EXCHANGED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE : RIGHT HIP.

  Patient problems: Pain

  MAUDE report 20493454 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD HEAD AND LINER EXCHANGE FOR POSSIBLE INFECTION. INFECTION UNKNOWN. NO DELAY IN SURGERY. DOI- (B)(6) 2024. DOR- (B)(6) 2024. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20463713 ↗
• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 20207126 ↗
• InjuryJul 16, 2024Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM A CHRONIC INFECTION AND WAS EXPERIENCING DISLOCATION OF HER PREVIOUS CEMENTED SPACER CONSTRUCT WITH A BIPOLAR HEAD. CEMENTED LINER, BIPOLAR OUTER AND INNER HEADS REMOVED. PATIENT WAS WASHED OUT AND THEN PREPPED FOR A MULTIHOLE CUP, 10 DEGREE LINER AND HEAD. NO SURGICAL SLOW DOWNS, DELAYS OR ISSUES. PATIENT STABLE AFTER. DOI: (B)(6) 2023 DOR: (B)(6) 2024 AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19754819 ↗
• InjuryApr 24, 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: LOOSE (ACETABULAR CUP) AND PAIN, AT REVISION THERE WAS FRETTING OF THE FEMORAL HEAD, AND THE ARTICULAR SURFACE SHOWS NECK IMPINGEMENT.

  Patient problems: Joint Laxity; Pain

  MAUDE report 19177026 ↗
• InjuryFeb 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR DISLOCATION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2009. DATE OF REVISION: (B)(6) 2023. DATE OF EVENT: 01 FEB 2024. (RIGHT HIP). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Joint Dislocation

  MAUDE report 18787089 ↗
• InjuryFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED WASHOUT. DOI: UNKNOWN, DOR: ON (B)(6) 2024, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18685624 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN, DOR- (B)(6) 2024 AFFECTED SIDE- LEFT HIP.

  Patient problems: Pain

  MAUDE report 18490229 ↗
• InjuryOct 17, 2023Fracture; Fracture

  PATIENT WAS REVISED DUE TO THE POLY WAS BROKE AND NEEDED NEW POLY AND EXCHANGED HEAD. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE : UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17949705 ↗
• InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED HIP WASHOUT. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17583626 ↗
• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A HEAD AND POLY SWAP FOR POSSIBLE INFECTION. UNABLE TO DETERMINE IF INFECTION IS PRESENT. (B)(6) 2023 DOR: (B)(6), 2023 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17539933 ↗
• InjuryMay 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2009, DATE OF REVISION: (B)(6) 2023, (RIGHT HIP). TREATMENT: HEAD AND LINER WERE REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 16985564 ↗
• InjuryMay 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTION. HEAD AND POLY WERE SWAPPED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2019, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16952086 ↗
• InjuryMay 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POSSIBLE INFECTED HIP. DOR: (B)(6) 2023. AFFECTED SIDE : RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16903361 ↗
• InjuryFeb 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED HIP WITH SPACER. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16350283 ↗
• InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS RETURNED TO SURGERY DUE TO JOINT INFECTION. THE HIP WAS WASHED OUT AND A NEW HEAD AND LINE WAS PLACED. THERE WAS NO LOOSENING, NO DELAYS, OR DEFICIENCIES. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16213832 ↗
• InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO I&D WASHOUT WITH EXCHANGE OF HEAD AND LINER DUE TO HEMATOMA. THERE WAS NO DELAY IN SURGERY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Hematoma

  MAUDE report 15925577 ↗