PINNACLE GRIPTION 1217-31-058Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295010234), received between Sep 25, 2018 and Nov 21, 2025 — classified as 11 injuries, 2 malfunctions.

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A HIP SURGERY AND CAME BACK AFTER 8 WEEKS BECAUSE THE LINER HAD LUXADED OUT OF THE CUP. PATIENT WAS REVISED.

  Patient problems: Insufficient Information

  MAUDE report 23622344 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. NO SURGICAL DELAY. DOI: UNKNOWN DOR: (B)(6) 2023 AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 17487774 ↗
• InjurySep 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT IS INFECTED AND WE ARE EXPLANTING COMPONENTS AND PUTTING IN A CEMENT SPACER. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15483928 ↗
• InjuryJul 28, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PINNACLE INSERT DISLOCATION POST-OP. DOI: (B)(6) 2014; DOR: (B)(6) 2022; RIGHT HIP.

  Patient problems: Pain

  MAUDE report 15122087 ↗
• MalfunctionJun 14, 2022Difficult to Insert; Off-Label Use; Difficult to Insert; Off-Label Use

  IT WAS REPORTED THAT CUP WAS PUT IN AND THE HOLE ELIMINATOR WOULD NOT PROPERLY FIT INTO HOLE, WAS SITTING PROUD . THREE WERE TESTED WITH DIFFERENT BATCHES SAME RESULT. NO ELIMINATOR WAS USED, CUP IS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14684984 ↗
• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UNSTABLE HIP. DOI: UNKNOWN. DOR: UNKNOWN. UNKNOWN HIP.

  Patient problems: Joint Laxity

  MAUDE report 13859990 ↗
• InjuryJun 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ORIGINAL TOTAL HIP REPLACEMENT (WHICH WAS REVISED AS A STAGE 1 REVISION IN (B)(6) OF 2020), WAS DONE ON (B)(6) 2018. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 11983593 ↗
• MalfunctionDec 22, 2020Difficult to Insert; Difficult to Insert

  SURGEON COULD NOT INSERT THE DOME HOLE COVER IN THE PINNACLE CUP. THE CUP WAS SUCCESSFULLY IMPLANTED. NO ADVERSE CONSEQUENCES KNOWN.

  Patient problems: Insufficient Information

  MAUDE report 11058113 ↗
• InjuryNov 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10835915 ↗
• InjuryApr 16, 2019No Apparent Adverse Event; No Apparent Adverse Event

  PPF ALLEGES STROKE AND HEART ATTACK AFTER FIRST REVISION. HEAD AND LINER WERE NON-DEPUY.

  Patient problems: Cardiac Arrest; Infarction, Cerebral

  MAUDE report 8519873 ↗
• InjuryFeb 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND IMPLANT RECORDS RECEIVED. PPF ALLEGES INFECTION AFTER THE FIRST REVISION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8353279 ↗
• InjuryFeb 5, 2019Loss of Osseointegration; Loss of Osseointegration

  LITIGATION ALLEGES THAT PATIENT HAS EXPERIENCED PAIN AND SWELLING. UPDATE: 6/20/2013 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS INDICATE THAT THE PATIENT WAS REVISED BECAUSE OF METALLOSIS, AND STEM LOOSENING. UPDATE AD 20 JUN 2018: (B)(4) HAS BEEN RE-OPENED TO (B)(4) DUE TO RECEIPT OF PPF AND MEDICAL RECORD. PPF ALLEGES LOOSENING OF CUP. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS ASEPTIC LOOSENING, RIGHT TOTAL HIP ARTHROPLASTY. DOI: (B)(6) 2010 - DOR: (B)(6) 2012, (RIGHT HIP).

  Patient problems: Inadequate Osseointegration; No Code Available; Pain; Swelling; Tissue Damage

  MAUDE report 8304466 ↗
• InjurySep 25, 2018Separation Problem; Separation Problem

  THE PATIENT WAS REVISED TO ADDRESS LINER DISASSOCIATION. DOI: (B)(6) 2017; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Not Applicable

  MAUDE report 7905624 ↗