PINNACLE ALTRX 1221-44-162Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295016625), received between Aug 13, 2018 and Apr 26, 2019 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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.

• InjuryApr 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGE PSEUDOTUMOR AND ELEVATED METAL IONS. STEM WAS ALREADY REPORTED IN FIRST PC. (RIGHT HIP).

  Patient problems: Tissue Damage

  MAUDE report 8556888 ↗
• InjuryApr 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES PSEUDOTUMOR. ALTHOUGH MEDICAL RECORDS WERE NOT PROVIDED, A DATA GIVEN STATING THAT PATIENT HAD A HISTORY OF RIGHT TOTAL HIP ARTHROPLASTY FAILURE WITH ,MULTIPLE REVISION INCLUDING HISTORY OF ABDUCTOR DEFICIENCY DUE TO METALLOSIS. IT WAS ALSO STATED THAT FEMORAL IMPLANT HAS SUBSIDED MORE THAN AN INCH AND IS GROSSLY LOOSE. DOI: (B)(6) 2004 - DOR: (B)(6) 2012 (RIGHT HIP).

  Patient problems: Tissue Damage

  MAUDE report 8508348 ↗
• InjuryNov 14, 2018Insufficient Device Problem Information; Noise, Audible; Insufficient Device Problem Information; Noise, Audible

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES ABDUCTOR MUSCLE REPAIR.

  Patient problems: Ambulation or Postural Difficulties; Cramp(s); Pain; Tissue Damage

  MAUDE report 8070079 ↗
• InjuryNov 2, 2018Fracture; Fracture

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES STROKE/HEART ATTACK, FRACTURE AND ELEVATED METAL IONS.

  Patient problems: Infarction, Cerebral

  MAUDE report 8032599 ↗
• InjurySep 24, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND MEDICAL RECORDS RECEIVED. PPF ALLEGES DISLOCATION WITH OPEN AND CLOSED REDUCTION AND LOOSENING OF THE CUP AFTER THE FIRST REVISION. AFTER REVIEW OF MEDICAL RECORDS FOR THE MDR REPORTABILITY, THE OPERATIVE NOTES DURING THE SECOND AND THIRD REVISION DOES NOT SUPPORT THE PPF ALLEGATION AFTER THE FIRST REVISION. HEAD, LINER, AND CUP WERE REPORTED TO THE IMPACTED PRODUCT DUE TO DISLOCATION AND LOOSENING OF THE CUP. DOI: (B)(6) 2009 - DOR: NONE REPORTED; (LEFT HIP). (B)(4), (LEFT HIP) FIRST REVISION. (B)(4), (LEFT HIP) SECOND REVISION. (B)(4), (LEFT HIP) THIRD REVISION.

  Patient problems: Joint Dislocation

  MAUDE report 7901451 ↗
• MalfunctionAug 13, 2018Material Disintegration; Adverse Event Without Identified Device or Use Problem; Material Disintegration; Adverse Event Without Identified Device or Use Problem

  PFS AND MEDICAL RECORDS RECEIVED. PFS ALLEGES LIMITED MOTION, CONSTANT PAIN, INFECTION OF ORIGINAL IMPLANT CAUSING NECESSITY OF REVISIONS, PAIN IN LEG AND NEUROPATHY IN BOTH LEGS. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY, PATIENT WAS REVISED TO ADDRESS PAIN AND INFECTION. REVISION NOTE STATED, THERE WAS ABOUT 3 ML OF VERY CLOUDY SYNOVIAL FLUID OUT WHICH ALMOST LOOKED PURULENT. THE HIP WAS DISLOCATED AND DID HAVE A LOT OF FIBRINOUS GROWTH WITHIN THE ACETABULAR AREA. THE STEM WAS WELL FIXED BUT FOUND TO HAVE SOME OSTEOLYSIS IN THE PROXIMAL FEMUR. THE PATIENT HAD A LOT OF BONE LOSS. IT WAS MENTIONED THAT THE SED RATE AND CRP WERE ELEVATED; HOWEVER HIS ASPIRATION WAS DRY. THERE WERE NO LABORATORY VALUES PROVIDED. DOI: (B)(6) 2010; DOR: (B)(6) 2016; (LEFT HIP).

  Patient problems: Host-Tissue Reaction; Injury; Limited Mobility Of The Implanted Joint; Loss of Range of Motion; Neuropathy; Not Applicable; Osteolysis; Pain; Unspecified Infection

  MAUDE report 7776259 ↗