PINNACLE 1217-07-066Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295008934), received between Mar 15, 2019 and Apr 5, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 5, 2019Loss of Osseointegration; Loss of Osseointegration

  LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, AND TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE AND BONE. UPDATE: SALES REP REPORTED REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS INSTABILITY. UPDATE: IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF CUP, METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. UPDATE: IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PFS ALLEGES THAT THE PATIENT FELT LIKE THERE WAS SCRAPING SENSATION IN HIS HIP, WALKING DIFFICULTY AND FALLING DOWN ON OCCASION. SURGEON RECOMMENDED REVISION SURGERY DUE TO LOOSE COMPONENT AND METALLOSIS. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS CUP LOOSENING, METALLOSIS AND INSTABILITY. REVISION NOTES REPORTED THAT HIP WAS FOUND TO BE DISLOCATED, SYNOVIAL SCARRING, AND GROSSLY LOOSE CUP. IT WAS ALSO FOUND THAT THE STEM IS 20 DEGREES RETROVERTED. THE SLEEVE WAS LEFT IN PLACE AND STEM WAS ROTATED OVER 40 DEGREES TO PROVIDE APPROPRIATE ANTEVERSION THEN WAS RE-INSERTED. PATHOLOGY REPORT IS POSITIVE FOR ACUTE INFLAMMATION. LAB DATA SHOWS METAL ION LEVELS WERE ABOVE 7 PPB. DOI: (B)(6) 2007; DOR: (B)(6) 2014; (RIGHT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; Inflammation; No Code Available; Pain; Scar Tissue; Tissue Damage

  MAUDE report 8486596 ↗
• InjuryMar 15, 2019Use of Device Problem; Loss of Osseointegration; Osseointegration Problem; Use of Device Problem; Loss of Osseointegration; Osseointegration Problem

  PPF ALLEGES LOOSENING OF CUP. DOI: (B)(6) 2009 - DOR: (B)(6) 2014 (RIGHT HIP). THIS PC IS FOR THE SECOND REVISION OF THE RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8424717 ↗