PINNACLE ALTRX 1221-32-258Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295016229), received between May 7, 2018 and Jul 30, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q2 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: THE PINNACLE LINER AND HEAD WERE REVISED FOR INSTABILITY LEADING TO DISLOCATION.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 22669363 ↗
• InjuryMay 12, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT EXPERIENCED RECURRENT HIP DISLOCATION FOLLOWING PRIMARY HIP SURGERY. DUE TO RECURRENT DISLOCATION DECISION WAS MADE TO REVISE THE LINER AND THE HEAD IN AN ATTEMPT TO INCREASE OFFSET.

  Patient problems: Joint Dislocation

  MAUDE report 14372321 ↗
• InjuryAug 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO INSTRUMENTS WERE BROKEN DURING THIS SURGERY. I DO NOT HAVE ACCESS TO ANY OF THE OTHER REQUESTED INFORMATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12362639 ↗
• InjuryJul 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2021; DOR: (B)(6) 2021; AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12245250 ↗
• InjuryOct 10, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND MEDICAL RECORDS RECEIVED. PPF ALLEGES DISLOCATION WITH CLOSED REDUCTION. AFTER REVIEW OF MEDICAL RECORDS, THERE WAS NO REVISION NOTES REPORTED. DOI: (B)(6) 2014; DOR: (B)(6) 2015; (RIGHT HIP).

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9175298 ↗
• InjuryMay 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION: PATIENT WAS REVISED TO ADDRESS SUSPECTED INFECTION. UPDATE RECEIVED 7/17/14. CLINICAL REPORT RECEIVED INDICATING THAT PATIENT SUFFERED FROM INFECTION. THERE IS NO FURTHER INFORMATION THAT WOULD AFFECT THE MDR DECISION. COMPLAINT WAS UPDATED ON (B)(6) 2014. (B)(4) IS A REOPEN OF (B)(4) DUE TO RECEIPT OF THE FOLLOWING INFORMATION: UPDATE PFS AND MEDICAL RECORDS RECEIVED. THERE WERE NO NEW ALLEGATIONS ADDED. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS INFECTION. REVISION NOTE STATED, UPON INCISING THROUGH THE FASCIA LATA PURULENT MATERIAL WAS ENCOUNTERED OVER THE TROCHANTER. WHEN THE HIP JOINT WAS OPENED UP THERE WAS SIGNIFICANT INTRAARTICULAR PURULENT MATERIAL ENCOUNTERED. THERE WAS CHRONICALLY INFECTED SYNOVIAL TISSUE AND CAPSULE. THE TRUNNION AND BALL OF THE FEMUR SHOWED CORROSIVE WEAR. RADIO-LOGICAL WORKUP INCLUDING ULTRASOUND AND ASPIRATION REVEALED PURULENT MATERIAL IN THE HIP JOINT. RADIO-LOGICAL WORKUP INCLUDING ULTRASOUND AND ASPIRATION REVEALED PURULENT MATERIAL IN THE HIP JOINT. CLINIC VISIT NOTED, THE PATIENT BEGAN TO HAVE TIGHTNESS AND SWELLING IN HER LEFT THIGH AND SHE NOTICED SOME R

  Patient problems: Ambulation or Postural Difficulties; Cellulitis; Not Applicable; Swelling; Unspecified Infection

  MAUDE report 7490365 ↗