PINNACLE GRIPTION 1217-32-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 10603295010340), received between Feb 15, 2013 and Mar 16, 2026 — classified as 60 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 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 60 reports, in the reporter's own words as published by the FDA.

• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION, IMPLANTS REMOVED. AFFECTED SIDE-RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24604302 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO AN INFECTED HIP. ALL PRODUCTS WERE REMOVED FOR A SPACER. NO HARM WAS DONE ALL PIECE WERE REMOVED. LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24532151 ↗
• InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ORIGINAL SURGERY DATE WAS SOMETIME IN 2014. THEY DO NOT HAVE RECORDS BUT THE SURGEON WAS ABLE TO GIVE US SIZES FROM HIS PRIMAL OP NOTE. THEY WILL NOT HAVE LOT # AS WELL. THE SURGEON SAID THE PT WAS COMPLAINING OF HIP PAIN. HIS ORIGINAL PLAN WAS TO DO A POLY SWAP AND HEAD EXCHANGE BUT ONCE IN THE SURGERY HE DEALT IT WOULD BE BETTER TO EXPLANT AND MAKE SURE IT WAS NOT INFECTED DUE TO WHAT HIS SOFT TISSUE LOOKED LIKE. HE EXPLANTED ALL COMPONENTS AND REPLACED WITH AN ANTIBIOTIC SPACER. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 23497202 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT¿S HIP WAS DISLOCATED AND CONCERNS OF INFECTION. SURGEON REPLACED CUP, LINER AND HEAD. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23357359 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH REMOVAL OF HIP DUE TO INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22481103 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION DUE TO INFECTED HIP. THIS IS STAGE 1 OF 2 STAGE REVISION. NO DELAY IN CASE. THE LOT NUMBERS ARE NOT KNOWN. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22338541 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO PROSTALAC DUE TO INFECTION. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22336799 ↗
• InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FOR A REVISION HIP CASE THAT THE SURGEON WILL USE A CUSTOM PINNACLE DUAL MOBILITY DEVICE FOR REVISION OF AN IN-SITU PINNACLE CUP. IMPLANTS IN SITU ARE: 1217-32-060 LOT: JM9830, 1221-52-160 LOT: JN3989, 1365-52-000 LOT: 3669907. THE INDICATION FOR REVISION IS INSTABILITY: RECURRENT DISLOCATION. THE ORIGINAL OPERATION WAS PERFORMED ELSEWHERE, SO WE HAVE LIMITED INFORMATION.

  Patient problems: Joint Laxity

  MAUDE report 22117302 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS HIGH CELL COUNT. SURGEON TOOK CUP, LINER, AND HEAD OUT TO DO A WASH. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21571338 ↗
• InjuryOct 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD FAILURE OF HIS POLYETHYLENE LINER. THERE HAS BEEN DISSOCIATION OF THE CUP FROM THE LINER. UNKNOWN SURGICAL DELAY. DATE OF IMPLANT AND EXPLANT UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20373439 ↗
• InjuryAug 23, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE PATIENT WAS REVISED AS THE INITIAL ACETABULAR COMPONENT DISASSOCIATED FROM ACETABULUM POST OPERATIVELY. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6), 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 20048416 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 18380445 ↗
• InjuryDec 19, 2023Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INFECTED HIP PROSTHESES WERE REMOVED AND A PROSTALAC WAS PLACED UNEVENTFULLY AFTER A THOROUGH DEBRIDEMENT AND I&D WERE PERFORMED. THE HEAD AND DM POLY LINER THAT WERE REMOVED HAD BEEN PLACED ON (B)(6) 2023 DUE TO DISLOCATION. THERE WAS NO SURGICAL DELAY AND NO PATIENT HARM OCCURRED. DOI: (B)(6) 2023(OTHER IMPLANTS). DOI: (B)(6) 2023(THE HEAD AND DM POLY LINER). DOR:(B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18358807 ↗
• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH INFECTION SO REMOVED ALL IMPLANTS TO ALLOW FOR INFECTION TO CLEAR. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2023. DOR: UNKNOWN. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18093908 ↗
• InjurySep 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION CONFIRMED, THAT THE AFFECTED SITE FOR THIS COMPLAINT WAS THE LEFT SIDE. NO REPORT OF ANY BROKEN INSTRUMENTS. DOI: (B)(6) 2023, DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17818389 ↗
• InjuryMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF A C-STEM PINNACLE CONSTRUCT DUE TO PERIPROSTHETIC FRACTURE. UPON EXPOSURE THEY DETERMINED THAT THE SITE WAS INFECTED TOO. THEY PERFORMED A TWO STAGE REVISION. THE FEMUR WAS FRACTURED INTO ABOUT 6 FRAGMENTS. ALL COMPONENTS WERE REMOVED (STEM, CUP, LINER, AND HEAD). THE FEMUR WAS CABLED BACK UP AND A RECLAIM PINNACLE DUAL MOBILITY CONSTRUCT WAS IMPLANTED. UNABLE TO PROVIDE ANY LOT NUMBERS.

  Patient problems: Fall; Unspecified Infection

  MAUDE report 16921031 ↗
• InjuryMar 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL RIGHT HIP. DOI: ON (B)(6) 2022, DOR: ON (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 16537126 ↗
• InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION . DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE : RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15951871 ↗
• InjuryNov 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN. DOI: ON (B)(6) 2021. DOR: ON (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 15880157 ↗
• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION: LITIGATION RECEIVED. LITIGATION ALLEGES PAIN, DISCOMFORT, AND ELEVATED METAL ION LEVELS IN THE BLOOD. DOI: (B)(6) 2011 ; DOR: (B)(6) 2015; (LEFT HIP).

  Patient problems: Discomfort; Foreign Body Reaction; Joint Laxity; Muscular Rigidity; Necrosis; Pain; Swelling/ Edema; Unspecified Musculoskeletal problem; Unspecified Tissue Injury

  MAUDE report 14251445 ↗
• InjuryApr 13, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT RESENTED WITH PAIN AND UPON X-RAY AND INVESTIGATION, CUP APPEARED LOOSE AT BONE TO IMPLANT INTERFACE. SURGERY WAS PERFORMED , REPLACING CUP WITH LARGER SIZE AND FITTED THE DUAL MOBILITY SYSTEM. PATIENT APPEARED TO HAVE EXCELLENT FIXATION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 14102739 ↗
• InjuryJan 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. DOI: (B)(6) 2021. DOR: (B)(6) 2021, (RIGHT HIP).

  Patient problems: Unspecified Infection

  MAUDE report 13226944 ↗
• InjurySep 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINIC NOTES AND RADIOLOGY REPORTS DATED (B)(6) 2016. PATIENT PRESENTS WITH PERSISTENT PAIN, TROCHANTERIC BURSITIS, HETEROTOPIC OSSIFICATION, AND WALKING DIFFICULTY FOLLOWING RIGHT HIP REVISION SURGERY. SERIAL RADIOGRAPHIC STUDIES IDENTIFY A WELL-FIXED, WELL-ALIGNED RIGHT THA WITH MINIMAL GLUTEAL EXTRASKELETAL OSSIFICATION. THE PATIENT RECEIVED THREE PAIN RELIEF INJECTIONS TO TREAT THE PAIN ON (B)(6) 2016. THE SURGEON NOTES THAT THE PATIENT WAS REFERRED FOR A RE-EVALUATION OF HIS MEDICATION FOR DEPRESSION. THE INJECTIONS AND MEDICATION ADJUSTMENT WERE SUCCESSFUL. THESES EVENTS WILL BE CAPTURED IN A NEW, LINKED PC, AS THEY ARE PREVIOUSLY UNREPORTED. DOI: (B)(6) 2014 (FOR STEM AND CUP); (B)(6) 2015 (FOR HEAD, LINER AND TITANIUM SLEEVE).

  Patient problems: Ambulation or Postural Difficulties; Extraskeletal ossification; Inflammation; No Code Available; Pain

  MAUDE report 10567002 ↗
• InjurySep 21, 2020Loss of Osseointegration; No Apparent Adverse Event; Loss of Osseointegration; No Apparent Adverse Event

  AFTER REVIEW OF THE MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS RIGHT FAILED TOTAL HIP ARTHROPLASTY FOR FEMORAL COMPONENT FRACTURE. OPERATIVE NOTE REPORTED OF BROKEN HEAD AND TRUNNION AND POSSIBLE LOCKING MECHANISM ISSUE OF THE CUP AND LINER. IT WAS ALSO INDICATED THAT THERE WAS A METAL DEBRIS FROM THE REMOVAL OF THE STEM. ADDED FACILITY NAME AND LEGAL ATTORNEY. THE HEAD AND LINER THAT WERE IMPLANTED ON (B)(6) 2015 WAS REPORTED UNDER (B)(4). DOI: (B)(6) 2014. DOR: (B)(6) 2020. RIGHT HIP (SECOND REVISION).

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions; No Code Available; Pain

  MAUDE report 10561892 ↗
• InjuryJun 24, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO LINER DISASSOCIATION, LINER FAIL. DOI: (B)(6) 2017, DOR: (B)(6) 2020, LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 10191941 ↗