PINNACLE ALTRX 1221-32-454Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295016304), received between Dec 6, 2017 and Feb 27, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED FROM MEDICAL RECORDS: LEFT TOTAL HIP ARTHROPLASTY (B)(6) 2013. RIGHT TOTAL HIP ARTHROPLASTY (B)(6) 2018. (B)(6) 2023 RADIOGRAPHS NOTED BILATERAL CEMENTLESS TOTAL HIP ARTHROPLASTY RIGHT SIDE DEPUY TRI-LOCK CERAMIC ON POLY AND LEFT SIDE DEPUY AML CERAMIC ON POLY. BROOKER III HETEROTOPIC OSSIFICATION ON RIGHT, BROOKER II HETEROTOPIC OSSIFICATION ON LEFT. (B)(6) 2024 MEDICAL RECORDS NOTE THE PATIENT¿S CHIEF COMPLAINT IS FOLLOW-UP BILATERAL TOTAL HIP ARTHROPLASTY WITH BILATERAL HETEROTOPIC OSSIFICATION. LEFT SIDE HAS MODERATE STIFFNESS AND SLIGHT PAIN. THE RIGHT SIDE HAS SEVERE STIFFNESS AND PAIN. RADIOLOGY REPORT NOTES RIGHT HIP HAS HETEROTOPIC OSSIFICATION WITH DEPUY RIGHT ARTHROPLASTY. DUE TO HIS CONDITION, A REVISION SURGERY ON (B)(6) 2024 WAS REQUIRED TO REMOVE THE BONE. THE LINER AND HEAD WERE ALSO CHANGED TO INCREASE STABILITY. FURTHER ADDITIONAL INFORMATION RECEIVED FROM SALES REPRESENTATIVE CONFIRMING ABOUT THE AFFECTED SIDE. RIGHT SIDE

  Patient problems: Extraskeletal ossification; Joint Laxity; Loss of Range of Motion; Muscular Rigidity; Pain

  MAUDE report 18787107 ↗
• InjuryOct 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED GRAM NEGATIVE BACTERIAL INFECTION. ALL IMPLANTS REMOVED AND ANTIBIOTIC SPACER IMPLANTED. ENCLOSED IS ALL THE INFO I HAVE FOR THIS PATIENT. NO SURGICAL DELAY. DOI: (B)(6) 2020; DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10684130 ↗
• InjuryNov 25, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS A SUSPECTED DISASSOCIATED POLY LINER. THIS SUSPICION WAS CONFIRMED DURING SURGERY. THE POLY LINER HAD COME LOOSE FOR SOME UNKNOWN REASON AND THE FEMORAL HEAD WAS ARTICULATING ON THE METAL SOCKET. THE SURGEON IS UNSURE WHY THE LINER DISSOCIATED. THE HEAD, SCREW AND LINER WERE REMOVED. A NEW LINER AND HEAD WERE IMPLANTED. THERE WAS METALLOSIS PRESENT AS WELL. DOI: (B)(6) 2018 - DOR: (B)(6) 2019 (RIGHT HIP).

  Patient problems: Foreign Body Reaction; No Code Available

  MAUDE report 9371939 ↗
• InjurySep 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFECTED HIP. REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. ALL COMPONENTS WERE WELL FIXED PRIOR TO REMOVAL. KNOWN NONCOMPLIANT PATIENT. PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? INFECTION, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES, IF YES, DESCRIBE: I&D REMOVAL OF IMPLANTS, ABX SPACER IMPLANTED,

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9072735 ↗
• InjuryMay 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POSSIBLE INFECTION. THERE IS DRAINAGE FROM TOTAL HIP FROM (B)(6) 2019.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8641525 ↗
• InjuryApr 15, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CHRONIC DISLOCATION SINCE ORIGINAL IMPLANTATION ON (B)(6) 2019.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8515251 ↗
• InjuryJan 30, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED FOR DISLOCATION. DOI: 2015; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8288582 ↗
• InjuryDec 6, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DER STATES THAT PATIENT WAS DISLOCATED POSTERIORLY AND THE LINER WAS EXCHANGED TO A +4 10 DEGREE.

  Patient problems: Joint Dislocation

  MAUDE report 7087071 ↗