PINNACLE GRIPTION 1217-30-066Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295010050), received between Nov 1, 2018 and Jul 14, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD ACUTE HIP INFECTION AND SURGEON DECIDED TO PERFORM SINGLE STAGE REVISION. ALL IMPLANTS WERE REMOVED AND HIP I&D DONE. THERE WERE NO COMPLAINTS OR DELAYS. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22499604 ↗
• InjuryMar 26, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A REVISION OF A RECLAIM BIMENTUM WAS DONE. THE REASON FOR REVISION WAS DUE TO INSTABILITY. THE PATIENT PREVIOUSLY HAD A GIRDLESTONE PROCEDURE, AND WAS LIKE THAT FOR A NUMBER OF YEARS. THE SURGEON NOTED THAT DURING THE PRIMARY SURGERY THEY WERE STABLE ON THE TABLE WITH A 24X95 RECLAIM BODY, BUT THEIR ADDUCTOR MUSCLES WERE GONE, AND SURROUNDING TISSUES WERE DYSFUNCTIONAL. AT SOME POINT AFTER SURGERY PATIENT MOVED INTO A POSITION (WHICH THE SURGEON ADVISED NOT TO) AND THEY DISLOCATED. THE RECLAIM BODY, BIMENTUM POLY AND 28+8.5 CERAMIC HEAD WERE REMOVED. CUP WAS RETAINED. THEN A LONGER BODY, NEW POLY AND 28+12 HEAD WERE IMPLANTED. THE SURGEON SAID THAT THE PATIENT'S SOFT TISSUES ARE VERY POOR, AND THEY HAVE NO ADDUCTOR MUSCLES. NO PREVIOUS REVISION HAD BEEN DONE FOR DISLOCATIONS. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 21696088 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER PRIMARY TOTAL HIP CASE, PATIENT SHOWED SIGNS OF INFECTION POSTOP SIX WEEKS. DR REMOVED THE CUP LINER AND SCREWS AND HEAD AND REPLACE THEM ALL. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN. DOR- (B)(6) 2024. AFFECTED SIDE- UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20522014 ↗
• InjuryNov 2, 2022Use of Device Problem; Use of Device Problem

  PATIENT WAS REVISED PROGRESSIVE RIGHT HIP PAIN AND INSTABILITY. ALTHOUGH THERE WAS NO CUP MOVEMENT, IT WAS DETERMINED TO BE TOO VERTICAL. THERE WAS NO DELAY IN SURGERY. DOI: (B)(6) 2017, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity; Pain

  MAUDE report 15716626 ↗
• InjuryFeb 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED AS 2 STAGE INFECTION WAS REPORTED. DOI: UNKNOWN; DOR: (B)(6) 2021; AFFECTED SIDE: UNKNOWN HIP SIDE.

  Patient problems: Fluid Discharge; Loss of Range of Motion; Necrosis; Pain; Unspecified Infection

  MAUDE report 13533849 ↗
• InjuryNov 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED HIP; SURGEON EXPLANTED COMPONENTS AND IMPLANTED PROSTALAC SPACER. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10853699 ↗
• InjuryAug 20, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  LITIGATION ALLLEGES PATIENT WAS REVISED DUE TO PAIN AND ELEVATED IONS LEVELS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF CUP. DOI: (B)(6) 2010.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8910221 ↗
• InjuryMay 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS IMPLANTED. THE INITIAL REVISION WAS OF JUST THE STEM SIDE ON (B)(6) 2019 AND ANOTHER REVISION TO TAKE OUT A ZIMMER CUP AND PUT IN OURS WAS DONE ON (B)(6) TO STOP THOUSAND PATIENT'S RIGHT HIP WAS REVISED DUE TO SECTION. ALL COMPONENTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS IMPLANTED. RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8583279 ↗
• InjuryFeb 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PAIN AND DIFFICULTY AMBULATING. UPDATED: IN ADDITION TO PREVIOUS ALLEGATIONS, PPF ALLEGES INFECTION. DOI: (B)(6) 2010; DOR: (B)(6) 2011; (RIGHT HIP).

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 8349586 ↗
• InjuryNov 1, 2018Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available; Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES LOOSENING OF CUP AFTER FIRST REVISION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8027606 ↗