PINNACLE GRIPTION 1217-16-062Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295009351), received between Nov 14, 2018 and Aug 20, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2024Osseointegration Problem; Osseointegration Problem

  THE PATIENT'S PINNACLE REVISION CUP AND CONSTRAINED LINER PARTIALLY PULLED OUT OF THE ACETABULUM. THE SURGEON REMOVED THE CONSTRAINED LINER, ACETABULAR CUP AND FIVE SCREWS. A NEW REVISION CUP AND DUAL MOBILITY LINER WERE PLACED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20003390 ↗
• InjuryOct 31, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT HAD REVISION OF HARDWARE DUE TO LOOSE CUP. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15699565 ↗
• InjuryApr 21, 2021Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED AS ACETABULAR SHELL IMPLANT LOOSENING/MOVEMENT. IT WAS INDICATED THAT THERE WAS LOOSENING OF THE CUP AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2020, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11704521 ↗
• InjuryNov 14, 2019Loss of Osseointegration; Migration; Loss of Osseointegration; Migration

  IT WAS REPORTED THAT THE PATIENTS ACETABULAR COMPONENT FAILED AND COLLAPSED INTO THE PATIENTS PELVIS. DR (B)(6) WAS UNSURE OF ORIGINAL IMPLANT DATE, BUT THE FIRST REVISION DATE WAS (B)(6) 2019. DR LES PERFORMED THAT REVISION AS WELL. THE PINNACLE REVISION CUP WAS LOOSENED AT BONE TO IMPLANT INTERFACE AND WAS TAKEN OUT, ALONG WITH THE SCREWS, LINER, AND 40MM +15.5 FEMORAL HEAD. DR (B)(6) PREPARED THE ACETABULUM FOR A 74MM REVISION PINNACLE CUP AND PLACED SEVERAL SCREWS IN TO SECURE THE CUP. A 40MM +5 FEMORAL HEAD WAS TRIALED AND FOUND TO BE SATISFACTORY. THE REAL HEAD WAS IMPLANTED AND THE CLOSING PROCESS BEGAN. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9324267 ↗
• InjuryNov 14, 2018Loss of or Failure to Bond; Osseointegration Problem; Loss of or Failure to Bond; Osseointegration Problem

  PATIENT ALLEGES PAIN, DISCOMFORT, INFLAMMATION, POPPING AND SNAPPING AND ELEVATED METAL ION LEVELS, PSEUDOTUMOR, LOOSENING OF CUP, METAL WEAR METALLOSIS, AND ELEVATED METAL IONS. DOI: (B)(6) 2009 - DOR: (B)(6) 2014 (RIGHT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; Inflammation; Pain

  MAUDE report 8070420 ↗