PINNACLE GRIPTION 1217-30-052Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10603295009986), received between Aug 10, 2017 and Jun 1, 2026 — classified as 36 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (8 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON NOVEMBER 26, 2019, THE PATIENT UNDERWENT THA SURGERY FOR HIP OA WITH THE PRODUCTS IN QUESTION AT ANOTHER HOSPITAL.THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY.LINER DISSOCIATION OCCURRED, AND THE FUTURE TREATMENT PLAN IS CURRENTLY UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25355016 ↗
• InjuryFeb 9, 2026Naturally Worn

  PATIENT WAS REVISED DUE TO HEAD AND LINER EXCHANGE FOR POLY WEAR. SURGEON REPORTED THAT PATIENT WAS IN PAIN AND HAD LIMITED RANGE OF MOTION. UPON EXPLANT, SIGNIFICANT POLY WEAR WAS EXPERIENCED. THERE WAS TRANSFER DEBRIS ON THE HEAD FROM ARTICULATING IN THE CUP (WAS BLACK). NEW LINER WAS SEATED INTO CUP ADEQUATELY. NEW HEAD WAS IMPLANTED. DOI: (B)(6) 2011, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 24291249 ↗
• InjuryJan 29, 2026Osseointegration Problem

  PATIENT HAD AVN OF THE FEMORAL HEAD AND HAD A TOTAL HIP DONE ON (B)(6) 2025. OVER THE PAST MONTH, THE PATIENT HAS FALLEN MULTIPLE TIMES AND HAS NOW FRACTURED THEIR PELVIS AND BROKE THEIR CUP LOOSE. ACTIVITY LEVEL - YES. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Bone Fracture(s); Fall; Inadequate Osseointegration

  MAUDE report 24210098 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS ON DIALYSIS, FELL AND BROKE HER HIP IN JUNE. A TOTAL HIP WAS DONE THEN; SHE HAD A LINER AND HEAD REVISION ON (B)(6) 2025 BECAUSE SHE DISLOCATED MULTIPLE TIMES. SOMEWHERE BETWEEN (B)(6) 2025 AND TODAY SHE DISLOCATED AGAIN. SHE WAS NOT AT THE HOSPITAL FOR HIP PAIN BUT THEY TOOK AND X RAY ANYWAY AND FOUND IT TO BE DISLOCATED. PATIENT ALSO HAD WHAT WAS BELIEVED TO BE A SINUS TRACK ON HER SCAR SO THE DOCTOR DECIDED TO DO AN EXPLANT WITH GIRDLE STONE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain; Unspecified Infection; Wound Dehiscence

  MAUDE report 23974085 ↗
• InjuryMay 29, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE CUP WAS REVISED FOR LOOSENING AFTER ACETABULAR FRACTURE. THE CUP WAS LOOSE AND THE LOOSENING INTERFACE WAS NON-CEMENTED. DOI: (B)(6) 2021, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 22107658 ↗
• InjuryDec 31, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT A THA FOR LEFT HIP JOINT OA. THE PROCEDURE PROCEEDED WITH THE REGULAR TECHNIQUE. HOWEVER, ACETABULAR REAMING WAS SHALLOW, AND SUFFICIENT FIXATION OF THE CUP WAS NOT ACHIEVED. THERE WAS A CRACK IN THE FEMUR FOR THE STEM SIDE, SO THAT SUFFICIENT REDUCTION COULD NOT BE DONE WITH A CABLE. SUBSEQUENTLY, THE STEM SIZE WAS CHANGED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER SURGERY, THE PATIENT COMPLAINED OF PAIN. THE SURGEON GUESSED THAT IT MIGHT BE DUE TO CUP LOOSENING. ON (B)(6) 2024, A REVISION SURGERY WAS PERFORMED. THE SURGEON REMOVED THE CUP EASILY BY PUTTING IN A CHISEL A FEW TIMES. THE ACETABULAR ROOF WAS REAMED AGAIN, AND THE CUP WAS REPLACED. THE STEM SIDE WAS NOT LOOSENING, SO THAT THE STEM WAS LEFT AS IT WAS. THE INNER HEAD WAS REPLACED WITH A DELTA TS. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE X-RAY SHOWED NO PROBLEMS. NO FURTHER INFORMATION IS AVAILABLE. THIS PC IS RELATED TO (B)(4) WHICH REPORTS THAT SUFFICIENT FIXATION COULD NOT BE ACHIEVED DURING THE PRIMARY SURGERY. THIS PC REPORTS THAT THE CUP LOOSENING OCCURRED AFTER THE PRIMARY SURGERY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21048325 ↗
• InjuryNov 7, 2024Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT THE CUP DISPLACED AND BROKE MULTIPLE SCREWS. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 20631898 ↗
• InjurySep 23, 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. THE SALES REP PROVIDED THE IMPLANTS PLACED DURING THE INITIAL PROCEDURE

  Patient problems: Unspecified Infection

  MAUDE report 20278883 ↗
• MalfunctionMay 28, 2024Difficult to Insert; Difficult to Insert

  DESPITE USING THE SAME CUP SIZE AS THE TRIAL, THE REQUIRED PRIMARY FIXATION WAS NOT ACHIEVED WHEN THE IMPLANT WAS PLACED. SURGERY WAS DELAYED 5 MINUTES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19404671 ↗
• InjuryMay 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. IMPLANTS WERE EXPLANTED AND PROSTALAC WAS PUT IN. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19238025 ↗
• InjuryApr 12, 2024Use of Device Problem; Osseointegration Problem; Use of Device Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT HAD REVISION HIP, EXPLANTATION OF PINNACLE CUP, DUAL MOBILITY METAL AND POLY LINER, AND S-ROM HEAD DUE TO POOR CUP FIXATION AND POSITION. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19100070 ↗
• InjuryApr 8, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND HAD IMPLANTS BECAME LOOSE. DOI: (B)(6) 2024 DOR: (B)(6) 2024 AFFECTED SIDE : RIGHT HIP.

  Patient problems: Fall; Inadequate Osseointegration

  MAUDE report 19067010 ↗
• InjuryFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6), STUDY NO: DOTS. CLINICAL NOTIFICATION RECEIVED, FOR REVISION, DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2014, DATE OF REVISION: (B)(6) 2023. (RIGHT HIP). TREATMENT: STEM, HEAD, LINER, AND SHELL REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 18740100 ↗
• InjuryJan 24, 2024Fracture; Fracture

  ADDITIONAL INFORMATION RECEIVED: A. CAN YOU PLEASE PROVIDE THE ORIGINAL IMPLANTATION DATE? (B)(6) 2024. B. WAS THERE ANY PATIENT HARM RELATED TO THE EVENT? THERE WAS A 1 HOUR DELAY IN THE PROCEDURE. C. KINDLY CONFIRM THE ALERT DATE OF THE COMPLAINT? WHEN WERE YOU MADE AWARE OF THE EVENT? (B)(6) 2024. D. KINDLY VERIFY THE EVENT DATE? 11TH JAN 2024. E. DID IT BREAK INTO TWO OR MORE PIECES? IF YES, WERE ALL THE FRAGMENTS RETRIEVED FROM THE PATIENT? YES, IT BREAK INTO MORE THAN TWO PIECES. AND THE FRAGMENTS RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18571450 ↗
• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION, SURGEON REMOVED ALL IMPLANTS AND REPLACED WITH TEMPORARY ANTIBIOTIC SPACER ACTIVITY LEVEL - YES. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2017, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 18314866 ↗
• InjurySep 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17725691 ↗
• InjuryApr 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRIMARY SURGERY WAS PERFORMED VIA THA. THE DETAILS ARE UNKNOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON (B)(6) 2019, THE REVISION SURGERY WAS PERFORMED VIA THA TO REPLACE THE HEAD AND THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON (B)(6) 2023, IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISLOCATION SEVERAL TIMES. THE REVISION SURGERY WILL BE PERFORMED ON (B)(6) 2023 TO REPLACE THE HEAD AND THE LINER. ON (B)(6) 2023, THE RE-REVISION SURGERY WAS STARTED AT 13:30. WHEN THE SURGEON OPENED THE WOUND FOR METAL HEAD REMOVAL, IT WAS CONFIRMED THAT THE POLYETHYLENE LINER HAD ALREADY BEEN COME OFF. THREE OF THE FOUR SCREWS LOOSENED, PRESUMABLY PUSHING OUT THE POLYETHYLENE LINER. THE SCREWS WERE REPLACE TO THE NEW ONES AND THE LINER WERE REPLACED TO 36MM NEUTRAL LINER IMPLANT. THE SURGEON PREFORMED THE TRIAL HEAD TO RECONSTRUCT AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY USING 36 MM + 0 HEAD IMPLANT.

  Patient problems: Insufficient Information

  MAUDE report 16732265 ↗
• InjuryMar 31, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT HAD A HIP DISLOCATION AFTER A FALL. SURGEON CHOSE TO REVISE SHELL TO COMPETITIVE ACETABULAR SHELL. FEMORAL HEAD WAS REMOVED FROM A SURGERY ON (B)(6) 2014. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2014, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Joint Laxity

  MAUDE report 13964050 ↗
• MalfunctionNov 1, 2021Osseointegration Problem; Migration; Osseointegration Problem; Migration

  SUBJECT ID: 007-04576; STUDY: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR MEDIAL ACETABULAR WALL FX WITH MILD MIGRATION AND LOOSENING OF THE CUP. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS RELATED TO DEVICE AND NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2020; DATE OF EVENT: (B)(6) 2021; (RIGHT HIP).

  Patient problems: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 12727762 ↗
• InjuryJul 21, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SURGEON OPENED THE CAPSULE HE SAW THE LINER WAS DISASSOCIATED FROM CUP. PATIENT CAME IN WITH STABILITY ISSUES. BROWN REVISED HEADBALL AND LINER. EXTRACTED LINER DIDN¿T APPEAR TO HAVE SCREW HEAD MARKS. IMPLANTS ARE NOT AVAILABLE FOR REVIEW. DOI: (B)(6) 2021 - DOR: (B)(6) 2021 (RIGHT HIP).

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

  MAUDE report 12206692 ↗
• InjuryNov 12, 2020Malposition of Device; Malposition of Device

  THE PATIENT WAS REVISED DUE TO EXPERIENCING HIP DISLOCATIONS. REMOVED WELL FIXED CUP, SCREW, LINER AND HEAD. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2020, UNKNOWN HIP.

  Patient problems: No Code Available

  MAUDE report 10830622 ↗
• InjuryJun 2, 2020Use of Device Problem; Loss of Osseointegration; Malposition of Device; Use of Device Problem; Loss of Osseointegration; Malposition of Device

  IT WAS REPORTED THAT THE CUP ALIGNMENT IS CAUSING PAIN. IT WAS ALSO INDICATED THAT THERE WAS A LOOSENING OF THE CUP AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2019. DOR: (B)(6) 2020; LEFT SIDE.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 10109205 ↗
• InjuryDec 3, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  PATIENT REVISED DUE TO LOOSENING OF THE CUP AT BONE TO IMPLANT INTERFACE. A NEW RECLAIM BODY AND HEAD WERE IMPLANTED. DOI: (B)(6) 2018; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9403932 ↗
• InjuryNov 21, 2019Adverse 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. IT WAS REPORTED THAT REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2019 DUE TO INFECTION. THE STEM (P/N: 3L92502), THE HEAD (P/N: 136550000), THE LINER (P/N: 122436052), THE CUP 8P/N: 121730052) WERE EXPLANTED AND INDWELLING THE CEMENT BEADS. THE SURGERY WAS COMPETED, AND IT WAS UNKNOWN WHETHER THERE WAS A SURGICAL DELAY OR NOT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9357226 ↗
• InjuryNov 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED, CUP, LINER, AND HEAD WERE EXCHANGED. DOI: (B)(6) 2019; DOR: (B)(6) 2019; UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9357110 ↗