PINNACLE GRIPTION 1217-30-056Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10603295010005), received between Jul 25, 2017 and Oct 15, 2024 — classified as 1 death, 34 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (11 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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PELVIC FRACTURE AND INFECTION. THERE WAS A ACETABULAR CUP LOOSENING AT NON-CEMENTED INTERFACE. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; Unspecified Infection

  MAUDE report 20451462 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD 1STAGE HIP REVISION, REMOVED IMPLANTS AND PUT NEW IMPLANTS IN BECAUSE OF POSSIBLE INFECTION. THERE WAS NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN HIP SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 20292343 ↗
• InjuryMay 2, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT SUFFERED ACETABULAR FRACTURE, RESULTING IN LOOSENING OF CUP. THE CUP WAS REMOVED AND HIP REVISED TO NEW MULTIHOLE CUP/LINER. THERE WERE NO DELAYS OR COMPLAINTS ABOUT THE IMPLANTS. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 16854627 ↗
• InjuryAug 25, 2022Device Dislodged or Dislocated; Naturally Worn; Noise, Audible; Device Dislodged or Dislocated; Naturally Worn; Noise, Audible

  PATIENT UNDERWENT AN ACETABULAR REVISION OF HER PRIMARY HIP ON THE (B)(6) 2021 (INITIAL COMPONENT WAS A STRYKER CUP AND STEM - PATIENT HAD A FALL RESULTING IN THE NEED FOR THE PRIMARY REVISION). THE PATIENT HAS BEEN COMPLAINING OF PAIN AND SQUEAKING IN HER HIP FOR A FEW WEEKS, SO THE SURGEON DID A FOLLOW UP X-RAY AND NOTED THAT THE LINER OF THE PINNACLE CUP USED IN THE REVISION IN 2021 HAD FAILED AND THAT THE PATIENT REQUIRED RE-REVISION OF THE HEAD AND LINER. UPON OPENING THE PATIENT, IT WAS NOTED THAT THE PINNACLE LINER HAD DISSOCIATED FROM THE PINNACLE SHELL AND THAT THE HEAD WAS ARTICULATING ON THE INSIDE OF THE SHELL. THERE WERE SIGNS OF METALOSIS IN THE TISSUES IMMEDIATELY AROUND THE HIP JOINT, THERE WERE ALSO SIGNS OF WEAR ON THE FEMORAL HEAD AND ACETABULAR SHELL. THE SURGEON ELECTED TO REVISE THE FEMORAL HEAD (STRYKER IMPLANT) AS WELL AS REPLACE THE PINNACLE LINER WITH A NEW ONE. DOI: (B)(6) 2021, DOR: (B)(6) 2022, UNKNOWN HIP.

  Patient problems: Discomfort; Fall; Foreign Body Reaction; Pain

  MAUDE report 15293166 ↗
• InjuryMay 10, 2022Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO PAINFUL HIP AND LOOSENING OF ACETABULAR SHELL AT THE BONE TO IMPLANT INTERFACE. THERE WAS NO SURGICAL DELAY. DOI- (B)(6) 2021; DOR- (B)(6) 2022; AFFECTED SIDE- LEFT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 14346003 ↗
• InjuryJan 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE COMPONENTS WERE REMOVED DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 13257795 ↗
• InjuryAug 16, 2021Migration; Migration

  IT WAS REPORTED THAT THE CUP SPUN OUT A COUPLE DAYS AFTER SURGERY. IT WAS ALSO INDICATED IN THE DER THAT THE CUP WAS LOOSE AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2021 DOR: (B)(6) 2021 LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 12325631 ↗
• InjuryJun 22, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE ACETABULAR COMPONENT AT THE BONE TO IMPLANT INTERFACE. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2011 - DOR: (B)(6) 2021 (LEFT HIP).

  Patient problems: Inadequate Osseointegration

  MAUDE report 12046413 ↗
• InjuryMay 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO TREAT PAIN. CUP, SCREWS, LINER, REVISED TO A COMPETITOR PRODUCT. NEW DEPUY HEAD WAS PAIRED WITH THE RETAINED CORAIL STEM.

  Patient problems: Pain

  MAUDE report 11855664 ↗
• InjuryMar 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2018 VIA THA. THE CAUSE OF THE REVISION SURGERY IS REPORTED REPETITIVE DISLOCATION THAT CAUSED BY IMPINGEMENT OF IMPLANTS. THE SURGERY WAS PERFORMED ON (B)(6) 2021, THE SURGEON FOUND WELL FIXATION OF IMPLANTS AND SUSPICION OF INFECTION, HE ONLY IRRIGATED AND COMPLETED THE SURGERY. THE CAUSE WAS NOT IMPINGEMENT, IT WAS INFECTION. THE STABILITY OF THE IMPLANT WAS IN GOOD CONDITION IN THIS EVENT.

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

  MAUDE report 11474120 ↗
• InjuryDec 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. ALL IMPLANTS WERE REMOVED AND REPLACEMENT OF A SPACER. NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT HIP.

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

  MAUDE report 11005095 ↗
• InjuryNov 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. ALL IMPLANTS WERE EXPLANTED. NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10803500 ↗
• InjurySep 3, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT COMPLAIN OF HIP PAIN, ACETABULAR CUP WAS LOOSE, REVISED CUP. DOI: (B)(6) 2019, DOR: (B)(6) 2020, UNKNOWN AFFECTED SIDE.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 10488012 ↗
• InjuryAug 14, 2020Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE CUP AT THE BONE TO IMPLANT INTERFACE. NO FURTHER INFORMATION PROVIDED. DOI: (B)(6) 2020, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 10408031 ↗
• InjuryJun 16, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THIS PATIENT RECENTLY HAD HER HIP REVISED BY SURGEON ON (B)(6) 2020 AT (B)(6) FOR AN UNSTABLE HIP. THIS PATIENT UNFORTUNATELY HAD A FALL AND LOOSENED HER ACETABULAR CUP THAT WAS IMPLANTED ON (B)(6) 2020. SURGEON EXPLANTED THE 56MM MULTIHOLE CUP, 40X56MM +4 10 DEGREE LINER , PINNACLE SCREWS, AND HIP BALL. A NEW ACETABULAR CUP, LINER, SCREWS, AND HIP BALL WAS IMPLANTED BACK AFTER THE NEW CUP WAS IMPLANTED AND WELL FIXED. THE EXISTING AML STEM WAS LEFT IN SITU. DOI: (B)(6) 2020; DOR: (B)(6) 2020; AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 10159701 ↗
• InjuryMay 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION, EXPLANTED THE COMPONENTS AND PUT IN A CEMENT SPACER. DOI: UNK. DOR ; (B)(6) 2020. LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10018590 ↗
• InjuryApr 15, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT HAD POOR BONE QUALITY AND ALSO A POSTERIOR ACETABULAR BONE DEFECT. ORIGINAL CUP DIDN¿T HAVE GOOD BONE INGROWTH BECAUSE OF THIS. IT WAS ALSO STATED THAT THERE WAS LOOSENING OF THE CUP. DOI: UNKNOWN. DOR: (B)(6) 2020; AFFECTED SITE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9962049 ↗
• InjuryMar 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNSTABLE. TRIFLANGE IMPLANTED. DOI: (B)(6) 2018; DOR: (B)(6) 2020; AFFECTED SITE: LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 9860239 ↗
• InjuryFeb 21, 2020Loss of Osseointegration; Migration; Loss of Osseointegration; Migration

  IT WAS REPORTED THAT THE PATIENT'S BONE STOCK WAS VERY POOR. CUP DISLOCATED OUT OF THE ACETABULUM. CUP, SCREWS, AND HEAD WERE REMOVED. UNIPOLAR HEAD WAS PUT ON THE STEM. SURGEON WAS ALSO WORRIED ABOUT INFECTION. DOI: (B)(6) 2020; DOR: (B)(6) 2020; RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9741815 ↗
• InjuryDec 4, 2019Loss of Osseointegration; Loss of Osseointegration

  PFS AND MEDICAL RECORDS RECEIVED. PFS ALLEGES SIGNIFICANT PAIN, LOOSE CUP AND INFECTION. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED FOR FAILED LEFT TOTAL HIP ARTHROPLASTY AND RIGHT KNEE ARTHRITIS. OPERATIVE FINDING IDENTIFIED GROSSLY LOOSE CUP AND FROZEN SECTION REVEALED MULTIPLE AREAS CONSISTENT WITH PERIPROSTHETIC JOINT INFECTION. PATIENT WAS IMPLANTED WITH PROSTALACS AND NON-DEPUY COMPONENTS. THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION ON (B)(6) 2018 TO REPAIR HER FRACTURED FEMUR DUE TO FALL.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain; Unspecified Infection

  MAUDE report 9411161 ↗
• InjuryJul 11, 2019Loss of Osseointegration; Loss of Osseointegration

  PPF AND STICKER SHEETS RECORD RECEIVED. PPF ALLEGES LOOSENING OF THE CUP AFTER FIRST REVISION. DOI: (B)(6) 2014, DOR: NONE REPORTED, (LEFT HIP).

  Patient problems: Inadequate Osseointegration

  MAUDE report 8780352 ↗
• InjuryJan 29, 2019Loss of or Failure to Bond; Loss of Osseointegration; Positioning Problem; Migration; Loss of or Failure to Bond; Loss of Osseointegration; Positioning Problem; Migration

  IT WAS REPORTED THAT THE PATIENT FELL AND DISLOCATED HIS HIP. DUE TO THE FALL, THE PATIENTS CUP POSITION HAD MOVED. IT WAS ALSO REPORTED THAT THE CUP WAS LOOSE AT THE BONE TO IMPLANT INTERFACE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8284950 ↗
• InjuryJan 28, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  PPF ALLEGES LOOSENING OF CUP, STEM AND DISLOCATION AFTER FIRST REVISION. DOI: (B)(6) 2014 - DOR: (B)(6) 2014 (LEFT HIP).

  Patient problems: Inadequate Osseointegration

  MAUDE report 8281003 ↗
• InjuryDec 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES INFECTION AFTER FIRST REVISION. DOI: (B)(6) 2010 - DOR: (B)(6) 2011 (RIGHT HIP).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8164970 ↗
• InjuryNov 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES INFECTION AND REVISION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8047947 ↗