PINNACLE GRIPTION 1217-30-054Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10603295009993), received between Aug 25, 2017 and Feb 12, 2026 — classified as 45 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (7 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 45 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2026Osseointegration Problem

  IT WAS REPORTED THAT THE SHELL/HEAD REVISED DUE TO INSTABILITY/FRACTURE. IT WAS STATED THAT THE SHELL WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS NON-CEMENTED. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; Joint Laxity

  MAUDE report 24327009 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR CUP AND LINER INSTABILITY, 25MM SCREW HEAD BROKE OFF WHEN TRYING TO EXTRACT SCREW. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 23821859 ↗
• InjuryNov 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE CUP MOVED CAUSING HIP TO DISLOCATE AND PULLING CONSTRAINED LINER OUT OF THE CUP. THIS PATIENT HAS HAD MULTIPLE HIP REVISIONS ON THIS HIP. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 23570254 ↗
• InjuryJul 21, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO METALLOSIS, LIKELY DUE TO NON-CEMENTED LOOSENING OF THE ACETABULAR CUP. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration

  MAUDE report 22554537 ↗
• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON REMOVED ALL PREVIOUS IMPLANTS AND IMPLANTED A SPACER DUE TO INFECTION. NO TIME ADDED. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22077287 ↗
• InjuryMay 16, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SCHEDULED REVISION SURGERY BECAUSE THEY WERE NOT SATISFIED WITH THERE PREVIOUS SURGERY. THE PATIENT HAD AN INITIAL TOTAL HIP PROCEDURE AND UNDERWENT A HIP REVISION SURGERY. CURRENTLY PATIENT HAS A PINNACLE GRIPTION SHELL, WITH SCREWS A LINER, AND A COMPETITOR STEM AND HEAD. DURING THE REVISION IT WAS NOTED THAT THERE WAS A LOOSE ACETABULAR CUP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22034719 ↗
• InjuryMay 7, 2025Osseointegration Problem; Osseointegration Problem

  "(B)(6) SCHOOL OF ENGINEERING AT (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO LOOSE ACETABULAR CUP. AT REMOVAL THE ACETABULAR LINER SHOWED MODERATE YELLOWING AND EMBEDDED METAL ON THE ARTICULAR SURFACE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21978801 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS REMOVED DUE TO INFECTION. SPACERS IMPLANTED, THERE WAS NO DELAY IN THE CASE AND THE PATIENT WAS NOT HARMED. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21126951 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SALES REP WAS INFORMED OF AN EVENT INVOLVING A POSSIBLE INFECTION WHILE DEPUY SYNTHES IMPLANTS WERE PLACED. IT IS UNKNOWN AT THIS TIME WHAT INTERVENTIONS HAVE TAKEN PLACE.

  Patient problems: Unspecified Infection

  MAUDE report 20290126 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON REMOVED ALL COMPONENTS FOR GIRDLESTONE. PATIENT FELL POST OP AND FRACTURED ACETABULUM. ACETABULUM COULD NOT ACCEPT CEMENTED LINER OR CUP. THERE WAS NO PRODUCT MALFUNCTION. THERE WAS NO DELAY, NO IMPLANTS OR FRAGMENTS LEFT BEHIND. IMPLANTED AT SAME HOSPITAL. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Bone Fracture(s)

  MAUDE report 20024772 ↗
• InjuryJan 24, 2024Use of Device Problem; Use of Device Problem

  PATIENT HAD EXPERIENCED MULTIPLE DISLOCATIONS POST THA. SURGEON ATTEMPTED TO CONVERT TO DUAL MOBILITY BUT HIP WAS STILL UNSTABLE. CUP WAS REMOVED AND A NEW CUP WAS PLACED WITH APPROPRIATE ANTEVERSION AND A DUAL MOBILITY ARTICULATION WITHOUT PATIENT HARM OR DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 18569919 ↗
• InjuryJan 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S CUP WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2020; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 16183515 ↗
• InjuryDec 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT HAD AN INFECTION. THE IMPLANT IN QUESTION WILL BE REMOVED, AND A SPACER MOLD WILL BE INSERTED ON DATE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2019. DOR: UNKNOWN. UNKNOWN SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 15932000 ↗
• InjuryApr 25, 2022Migration; Migration

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT A THA SURGERY WITH THE CUP, STEM, AND HEAD. AFTER SURGERY, ON UNKNOWN DATE, THE CUP MIGRATED. REVISION SURGERY PERFORMED (B)(6) 2022. DOI: (B)(6) 2021; DOR: (B)(6) 2022; UNKNOWN HIP.

  Patient problems: Insufficient Information

  MAUDE report 14194027 ↗
• InjuryMar 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. ALL IMPLANTS WERE REMOVED AND REPLACED WITH ANTIBIOTIC BEADS. DOI: (B)(6) 2016; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 13840130 ↗
• InjuryNov 17, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A PAINFUL HIP THAT HAD DISLOCATED RECENTLY. THE PATIENT HAD AN INTERMEDICS STEM THAT THE BONE HAD WORN AWAY AROUND THE CAL AT REGION. STEM WAS WELL FIXED THOUGH. SURGEON REMOVED CUP AND REPOSITIONED A NEW CUP. IT WAS ALSO INDICATED THAT THERE WAS LOOSENING OF THE CUP AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2019, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; Pain; Unspecified Tissue Injury

  MAUDE report 12833192 ↗
• InjuryNov 9, 2021Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT THE CONSTRAINED LINER AND SHELL PULLED OUT OF THE ACETABULUM. REVISED TO REV CUP WITH SCREWS AND NEUTRAL ALTRX LINER. NO SURGICAL DELAY. DOI: (B)(6) 2020. DOR: (B)(6) 2021, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Insufficient Information

  MAUDE report 12778485 ↗
• InjuryAug 25, 2021Migration; Migration

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE STEM AND ACETABULAR CUP WERE NOT LOOSE. IT WAS UNLIKELY THAT METALLOSIS AND OSTEOLYSIS HAS OCCURRED. THE LINER AND STEM WERE NOT REVISED ONLY THE CUP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Osteolysis

  MAUDE report 12367704 ↗
• InjuryAug 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2021, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

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

  MAUDE report 12367006 ↗
• InjuryAug 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED HIP. DOI: (B)(6) 2021 - DOR: (B)(6) 2021 (LEFT HIP).

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

  MAUDE report 12345212 ↗
• InjuryApr 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO TREAT INFECTION. DOI: UNK DOR: (B)(6) 2021 UNKNOWN HIP.

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

  MAUDE report 11711344 ↗
• InjuryNov 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAIN IN THEIR HIP. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2020, LEFT SIDE.

  Patient problems: No Code Available; Pain

  MAUDE report 10830806 ↗
• InjurySep 27, 2019Loss of Osseointegration; Loss of Osseointegration

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES LOOSENING OF CUP. DOI: (B)(6) 2011; DOR: (B)(6) 2014; (LEFT HIP). PLEASE SEE (B)(4) FOR THE FIRST REVISION.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9129706 ↗
• InjuryJun 4, 2019Use of Device Problem; Use of Device Problem

  SUBJECT ID: (B)(6). CLINICAL NOTIFICATION RECEIVED FOR LEFT HIP REVISION TO ADDRESS INSTABILITY AND MULTIPLE HIP DISLOCATIONS. DOI: (B)(6) 2015; DOR #1: (B)(6) 2018 (CUP, SCREWS, LINER, HEAD); DOR #2: (B)(6) 2018 (CUP, SCREW, LINER, HEAD), (LEFT HIP). MEDICAL RECORDS INDICATE ON (B)(6) 2018 PATIENT WAS REVISED FOR INSTABILITY, DISLOCATION, AND THE CUP WAS NOTED TO BE MALPOSITIONED. A COMPETITOR CUP WAS PLACED.

  Patient problems: No Code Available

  MAUDE report 8668431 ↗
• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES PULMONARY EMBOLISM AFTER FIRST REVISION. DOI: (B)(6) 2012 - DOR: NONE REPORTED (LEFT HIP).

  Patient problems: Pulmonary Embolism

  MAUDE report 8552050 ↗