PINNACLE GRIPTION 1217-30-064Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295010043), received between Oct 9, 2018 and Oct 24, 2024 — classified as 9 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE REASON THERE WERE 2 LINERS USED IN THIS CASE WAS DUAL MOBILITY. WE USE A PINNACLE DM LINER AND THEN A BIMENTUM LINER. SERF WILL RECEIVE NOTHING AS THE HOSPITAL PUTS THESE ON LEGAL HOLD. THE FEMORAL STEM WAS A BIOMET STEM.

  Patient problems: Unspecified Infection

  MAUDE report 20526773 ↗
• InjurySep 20, 2024Use of Device Problem; Use of Device Problem

  PATIENT WAS TO REVISE DUE TO PAIN AND IMPINGING ON THE CUP. HE HAD NOT DISLOCATED YET BUT WAS PAINFUL. CUP WAS VERTICAL AND THE STEM WAS UNDERSIZED. CUP AND STEM WERE REMOVED AND REPLACED WITH LARGER SIZE IMPLANTS. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity; Pain

  MAUDE report 20268879 ↗
• InjuryAug 24, 2023Use of Device Problem; Use of Device Problem

  THE SURGEON REVISED THE PATIENT'S ACETABULAR COMPONENT AND ADJUSTED THE CUP POSITION FOR IMPROVED STABILITY FOLLOWING DISLOCATION. THE PATIENT RECEIVED A NEW LINER AND HEAD BALL AFTER THE CUP POSITION WAS ADJUSTED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 17610395 ↗
• InjuryMay 9, 2022Use of Device Problem; Osseointegration Problem; Migration; Use of Device Problem; Osseointegration Problem; Migration

  LITIGATION RECORD RECEIVED. LITIGATION ALLEGES THAT THE PATIENT WAS DIAGNOSED WITH FIBROADIPOSE TISSUE AND FOCAL SYNOVIUM WITH CHRONIC INFLAMMATION, HEMOSIDEROSIS AND METALLOSIS. DOI: (B)(6) 2017, DOR: (B)(6) 2017, RIGHT HIP (SECOND REVISION).

  Patient problems: Bone Fracture(s); Foreign Body Reaction; Hematoma; Hemorrhage/Blood Loss/Bleeding; Inadequate Osseointegration; Inflammation; Pain

  MAUDE report 14336360 ↗
• InjurySep 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PT LT TOTAL HIP REVISED TO PROSTALAC SPACER DUE TO INFECTION. ORIGINAL LEFT TOTAL HIP (B)(6) 2020. NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 12469739 ↗
• InjurySep 27, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  LITIGATION ALLEGES PATIENT SUFFERS FROM TOXIC COBALT-CHROMIUM METAL IONS, PAIN, DISCOMFORT, AND INFLAMMATION. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF THE CUP. IT WAS NOTED THAT THE PATIENT HAD ESTIMATED BLOOD LOSS OF 1000 CC AND 450 CC BACK TO PATIENT. DOI: (B)(6) 2010; DOR: (B)(6) 2011; RIGHT HIP.

  Patient problems: Discomfort; Hemorrhage/Blood Loss/Bleeding; Inadequate Osseointegration; Inflammation; No Code Available; Pain

  MAUDE report 9129312 ↗
• InjuryFeb 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES INFECTION. DOI: (B)(6) 2008, DOR: JUL 23,2013, (LEFT HIP) (STEM); DOI: (B)(6) 2011, DOR: JUL 23, 2013, (LEFT HIP).

  Patient problems: Pain; Unspecified Infection

  MAUDE report 8296175 ↗
• InjuryJan 17, 2019Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT FELL AND ACETABULAR CUP BROKE LOOSE, REVISING THE CUP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8257295 ↗
• InjuryOct 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THAT PATIENT HAS SUFFERED SYMPTOMS INCLUDING BUT NOT LIMITED TO PAIN, SWELLING, INFLAMMATION, INFECTION, DAMAGE TO SURROUNDING BONE AND TISSUE, AND LACK OF MOBILITY. DOI: (B)(6) 2008 ; DOR: (B)(6) 2014 (LEFT HIP).

  Patient problems: Inflammation; Injury; Limited Mobility Of The Implanted Joint; Pain; Swelling; Unspecified Infection

  MAUDE report 7946924 ↗