PINNACLE GRIPTION 1217-30-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295010029), received between Jul 24, 2017 and Oct 21, 2025 — classified as 20 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (4 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD AN INFECTED HIP. THE IMPLANTS WERE REMOVED TO PUT IN A TEMPORARY SPACER. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23348140 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SURGERY ON (B)(6) 2025. PATIENT FELL AND PUSHED NEW ACETABULAR THROUGH MEDIAL WALL INTO THEIR PELVIS. ACETABULAR COMPONENT WAS RETRIEVED INCLUDING TWO SCREWS AND POLY STILL LOCKED INTO THE CUP. NEW DPX REVISION CUP WAS IMPLANTED WITH FIVE SCREWS. NEW 40MM POLY AND CERAMIC TS REVISION HEAD WERE IMPLANTED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 22214340 ↗
• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION AND THE SURGEON DID A SINGLE STAGE REVISION. SURGEON REMOVED ALL IMPLANTS, DID A THOROUGH I&D, AND PUT IN NEW IMPLANTS. THERE WAS NO DELAY IN PROCEDURE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21342937 ↗
• InjuryJan 21, 2025Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF CUP AT NON-CEMENTED INTERFACE. CUP WAS REMOVED AND HEAD WAS EXCHANGED. THERE WAS NO SURGICAL DELAY, NO PATIENT CONSEQUENCE. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21196911 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF TOTAL HIP. PATIENT FELL, FRACTURED ACETABULUM AND PELVIS, THE CUP PULLED OUT. REMOVED ALL COMPONENTS. END RESULT WAS A GIRDLESTONE.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 20147270 ↗
• InjuryJul 10, 2024Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF A PINN SHELL. SHELL, LINER, TWO SCREWS & FEMORAL HEAD REMOVED. STRYKER CUP AND TS CERAMIC HEAD WERE IMPLANTED. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19714431 ↗
• InjuryApr 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO CHRONIC INFECTION. REMOVAL OF ALL IMPLANTS TOOK PLACE. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16777591 ↗
• InjuryNov 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO POSTOPERATIVELY INFECTION. I & D WAS COMPLETED AND SURGEON DECIDED TO EXPLANT AND RE IMPLANT NEW IMPLANTS. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR : (B)(6) 2022. AFFECTED SIDE : LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15840436 ↗
• MalfunctionSep 8, 2022No Apparent Adverse Event; Inaccurate Information; No Apparent Adverse Event; Inaccurate Information

  EVENT DESCRIPTION: AN AR-MEDICA CLIENT CONTACTED US COMPLAINING THAT THE COUNTRY OF ORIGIN DOES NOT MATCH BETWEEN THE SHIPPING INVOICE AND THE BOX LABEL. AT THE MOMENT, CUSTOMS HAS IDENTIFIED 7 CODES IN THE DEPUY BUSINESS WITH SUCH A DISCREPANCY. PHOTOS OF CODES AND SHIPPING INVOICE ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15384495 ↗
• InjuryAug 3, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REMOVAL OF CUP, SCREW, HEAD, AND LINER DUE TO LOOSENING OF THE CUP AT THE BONE TO IMPLANT INTERFACE. REPLACED WITH A CUSTOM TRIFLING IMPLANT. NOTHING MORE TO REPORT. DOI: (B)(6) 2018; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15156283 ↗
• InjuryMar 4, 2022Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO 1 LOOSE SCREW AND 1 BROKEN SCREW. CUP WAS LOOSE AT BONE TO IMPLANT INTERFACE AND CAME OUT WITH JUST THE IMPACTOR HANDLE. TREPHINE WAS USED TO REMOVED BROKEN SCREW. THERE WAS NO SURGICAL DELAY. NO OTHER INFORMATION GIVEN. DOI: (B)(6) 2018, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 13665973 ↗
• MalfunctionNov 16, 2020Migration; Migration

  CLINICAL ADVERSE EVENT RECEIVED FOR ABNORMAL X-RAY - ACETABULAR MIGRATION: ABNORMAL RADIOGRAPHIC EVALUATION. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2011, DATE OF REVISION #1: (B)(6) 2016 (HEAD, LINER, CUP), DATE OF REVISION #2: (B)(6) 2017 (HEAD, LINER, CUP), DATE OF EVENT (ONSET): (B)(6) 2019, (RIGHT HIP). TREATMENT: NO INTERVENTION NEEDED. COMPONENTS ARE WELL FIXED AND STABLE. WILL REVIEW X-RAYS AT ANNUAL VISITS TO MONITOR FIXATION.

  Patient problems: No Code Available

  MAUDE report 10843036 ↗
• InjuryOct 7, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT CUP BECAME LOOSE AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2019. DOR: (B)(6) 2020; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 10643792 ↗
• InjuryMar 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A 2 YEAR INFECTED HIP, NOT DEPUY, THAT WAS REMOVED & ANTIBIOTIC SPACER INSERTED ON (B)(6) 2019. PATIENT WAS CLEARED OF INFECTION AND ON (B)(6) 2019, A DEPUY REVISION TOTAL HIP WAS IMPLANTED. IN (B)(6) 2020, THE PATIENT PRESENTED ANOTHER HIP INFECTION AND ALL IMPLANTS WERE REMOVED AND ANTIBIOTIC SPACER IMPLANTED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9883853 ↗
• InjuryJan 2, 2020Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  IT WAS REPORTED THAT THERE WAS AN EXCHANGE PARTS DUE TO SHELL POSITION AND RECURRENT DISLOCATION. EXCHANGE TO CONSTRAINED.

  Patient problems: No Code Available

  MAUDE report 9538005 ↗
• InjuryMay 9, 2019Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE SHELL, LINER, AND HEAD WERE REVISED TO ADDRESS LOOSENING OF THE CUP AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8595829 ↗
• InjurySep 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PROTRUSIO. IT WAS ALSO INDICATED THAT THE DOCTOR REMOVED THE CUP, SCREW AND HEAD. STEM WAS RETAINED. HE PUT IN A COMPETITIVE COMPANY CUP AND LINER AND REPLACED THE HEAD WITH A 40MM +12 ARTICUL/EZE HEAD. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Bone Fracture(s); Not Applicable

  MAUDE report 7842256 ↗
• InjuryJun 27, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  DER STATES THAT THE ORIGINAL IMPLANT DATE WAS UNKNOWN. THIS PATIENT HAD HER HIP REVISED WHERE A COMPETITOR HIP REPLACEMENT STEM WAS REMOVED AND REPLACED WITH A SUMMIT STEM AND PINNACLE CUP IN MAY. THE PATIENT CAME INTO THE ER WITH IN 2 WEEKS OF HER REVISION SURGERY COMPLAINING OF HIP PAIN. X-RAYS INDICATES THAT HER ACETABULAR CUP HAD MOST LIKELY CAME LOOSE AND PROTRUDED THROUGH THE MEDIAL ACETABULAR WALL. THE LOOSENING WAS ALLEGEDLY BONE TO CEMENT INTERFACE WITH COMPETITOR CEMENT HAVING BEEN USED. SHE WAS CONSULTED WHERE IT WAS DECIDED THAT HE WOULD EXPLANTED ALL COMPONENTS AND LET THE PELVIS TRY AND HEAL AND RECONSTITUTE BONE. ALL IMPLANTS WERE EXPLANTED. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Not Applicable; Pain

  MAUDE report 7641294 ↗
• InjuryJun 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PPF AND IMPLANT STICKER SHEET RECEIVED. PPF ALLEGES STROKE AND HEART ATTACK AFTER THE FIRST REVISION. DOI: (B)(6) 2012; DOR: NOT REPORTED; RIGHT HIP. (B)(4)- 1ST REVISION (RIGHT). (B)(4)- 1ST REVISION (LEFT). (B)(4)- 2ND REVISION (LEFT). (B)(4)- 3RD NOT REVISED (LEFT).

  Patient problems: Cardiac Arrest; Infarction, Cerebral

  MAUDE report 7620833 ↗
• InjuryApr 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF AN UNKNOWN COMPONENT AT THE BONE TO IMPLANT INTERFACE. ALL COMPONENTS REMOVED AND REPLACED WITH PROSTALAC STEM, HEAD AND CUP. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: No Code Available; Not Applicable; Unspecified Infection

  MAUDE report 7410693 ↗
• InjuryOct 5, 2017Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND CUP LOOSENING AT THE BONE/IMPLANT INTERFACE.

  Patient problems: No Information

  MAUDE report 6916727 ↗
• InjuryJul 24, 2017Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED TO ADDRESS ACETABULAR FRACTURE.

  Patient problems: Anxiety; Bone Fracture(s); Hematoma; Hip Fracture; Host-Tissue Reaction; Necrosis; Not Applicable; Pain

  MAUDE report 6736871 ↗