PINNACLE ALTRX 1221-40-464Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295393542), received between Mar 4, 2019 and Jul 27, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient had potential infection, so surgeon removed old liner and head ball.DOI: (b)(6) 2026,DOR:(b)(6), 2026,Affected Side: Unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50036185 ↗
• InjuryAug 5, 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: LEFT HIP.

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

  MAUDE report 12281207 ↗
• InjuryJun 7, 2021Adverse 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 AN UNSTABLE HIP. SURGEON EXPLANTED HEAD AND LINER REVISING WITH PINNACLE MDM. DOI: (B)(6) 2020; DOR: (B)(6) 2021; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 11948328 ↗
• InjuryFeb 22, 2021Off-Label Use; Device Dislodged or Dislocated; Off-Label Use; Device Dislodged or Dislocated

  IT WAS INDICATED THAT PATIENT HAD AN ANTIBIOTIC SPACER PLACED ON (B)(6) 2021. PATIENT FELL AND DISLOCATED HIS HIP. HE ALSO BROKE THE ACETAULAR CUP SPACER AWAY FROM HIS BONE DURING THIS FALL. A NEW ACETABULAR COMPONENT WAS CEMENTED IN PLACE AND THE NECK LENGTH WAS UPSIZED. PATIENT IS A NON COMPLIANT PATIENT PER DOCTOR. LOOSENING INTERFACE IS BONE TO CEMENT AND THE CEMENT MANUFACTURER IS UNKNOWN. DOI: (B)(6) 2021, DOR: (B)(6) 2021.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 11358784 ↗
• InjuryDec 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATE AD 21 APR 2022: PFS, PPF, AND MEDICAL RECORD RECEIVED. THIS WAS REVIEWED BY CLINICIAN AND HAVE THE FINDING THAT ON (B)(6) 2017, HEAD/LINER/CUP RIGHT HIP (POLY ON CERAMIC) THE PATIENT HAD A REVISION RIGHT TOTAL HIP ARTHROPLASTY TO ADDRESS FAILED RIGHT TOTAL HIP ARTHROPLASTY. THE INDICATIONS FOR SURGERY INCLUDED, SUDDEN ONSET OF PAIN. RADIOGRAPHS SHOWED EVIDENCE OF DISPLACEMENT OF THE ACETABULAR COMPONENT WITH EVIDENCE OF AN ACETABULAR FRACTURE. DURING THE PROCEDURE, THE SURGEON OBSERVED, THE CUP AND TWO SCREWS WERE REMOVED, THE CUP WAS NOTED TO BE GROSSLY LOOSE. ZIMMER PRODUCTS WERE USED ALONG WITH DEPUY FEMORAL HEAD. ((B)(6) 2017 STICKER PAGE 11 OF 11) CT SCAN DATED (B)(6) 2017 FINDINGS STATED THAT THERE IS SUPERIOR, LATERAL AND POSTERIOR DISPLACEMENT PLUS ABNORMAL VERTICAL ANGULATION OF THE ACETABULAR CUP IN RELATION TO THE NATIVE ACETABULUM IN KEEPING WITH CUP DISLOCATION , PSEUDOARTHROSIS,HEMARTHROSIS, HEMATOMA, EDEMA, AND FLUID. ADDED BIPOLAR HEAD, CUP AND SCREWS TO THIS COMPLAINT. UPDATED PRODUCT DETAILS OF HEAD AND LINER AND ADDED PATIENT'S INITIALS, AGE, DOB, GENDER, AND MEDICAL HISTORY. CORRECTED DOI. DOI: (B)(6) 2017 - DOR: (B)(6) 2017 (RIGHT HIP).

  Patient problems: Foreign Body Reaction; Hematoma; Hemorrhage/Blood Loss/Bleeding; Inflammation; Pain

  MAUDE report 10991627 ↗
• InjuryOct 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION WAS USED AS A WASHOUT/DEBRIDEMENT FOR INFECTION WITH HEAD AND LINER EXCHANGE. DOI: (B)(6) 2020 DOR: (B)(6) 2020 AFFECTED SIDE: LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10615250 ↗
• InjuryMar 25, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PFS HAS INDICATED THAT THE PATIENT HAD PREVIOUSLY DISLOCATED THREE TIMES PRIOR TO BEING REVISED; THESE WERE ALL TREATED WITH CLOSED REDUCTION. AFTER REVIEW OF MEDICAL RECORDS, IT WAS STATED THAT THE PATIENT WAS REVISED DUE TO RECURRENT DISLOCATION. REVISION NOTES REPORTED A 35 DEGREES OF COMBINED ANTEVERSION. DOI: (B)(6) 2015 - DOR: (B)(6) 2016 (LEFT HIP).

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8448228 ↗
• InjuryMar 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CAME INTO OFFICE WITH INFECTION IN CLOSURE. THE DOCTOR OPTED FOR AN I AND D AND ALSO CHANGED POLY AND HEAD. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8386607 ↗