PINNACLE GRIPTION 1217-31-048Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295010180), received between Mar 20, 2018 and Mar 7, 2025 — classified as 16 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryMar 7, 2025Use of Device Problem; Noise, Audible; Use of Device Problem; Noise, Audible

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE REAASON FOR REVISION WAS DUE TO IMPLANT FRACTURED/BROKEN/CRACKED/CHIPPED.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 21552413 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS INSTABILITY AND FREQUENT DISLOCATIONS INVOLVING THE DUAL MOBILITY LINER.

  Patient problems: Joint Laxity

  MAUDE report 20696226 ↗
• InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A CONCERN WITH A HIP REPLACEMENT AND LATER, DEVELOPED A POSTERIOR INFECTION .

  Patient problems: Unspecified Infection

  MAUDE report 17623651 ↗
• InjuryJul 14, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT CERAMIC PINNACLE INSERT IS BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 17324077 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2023 DUE TO SUB-LUXATING HIP AT EXTREME RANGE OF MOTION. SURGEON WAS HESITANT TO REVISE THE PATIENT, BUT THE PATIENT WAS UNABLE TO LIVE WITH THE SUB-LUXATING HIP AND COULD NOT AVOID THOSE POSITIONS. THE CUP/LINER/HEAD WERE REMOVED AND REVISED TO A BI-MENTUM CONSTRUCT. DOI: ON (B)(6) 2022, DOR: ON (B)(6) 2023, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 16373783 ↗
• InjuryJan 27, 2023Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO SURGICAL DELAY REPORTED. THE PATIENT NOTICED "CRACKING" AT THE AREA OF THE RIGHT HIP SINCE ABOUT 4 MONTHS. THE PAIN EXTENDS TO THE SPINE. NO KNOWN TRAUMA. AFTER IMPLANTATION OF A RIGHT HIP.

  Patient problems: Insufficient Information; Pain

  MAUDE report 16252689 ↗
• MalfunctionJul 8, 2022Difficult to Insert; Difficult to Insert

  THE SURGEON IMPLANTED THE PINNACLE HUNDRED SERIES CUP. WHEN HE ATTEMPTED TO PUT THE HOLE ELIMINATOR IN HE SAID THAT HE COULDN¿T GET THE TREADS TO LINE UP AND GET THE HOLE ELIMINATOR TO ENGAGE. HE TRIED THREE TIMES, TAKING THE HOLE ELIMINATOR OUT EACH TIME AND TRYING TO GET IT IN AT A DIFFERENT ANGLE. I THEN OPENED ANOTHER HOLE ELIMINATOR AND HE HAD THE SAME PROBLEM, HE ATTEMPTED TO ENGAGE THIS SECOND HOLE ELIMINATOR TWICE. HE DECIDED TO LEAVE THE CUP IMPLANTED WITHOUT A HOLE ELIMINATOR IN SITU AND PROCEEDED WITH THE REST OF THE SURGERY. THE SURGERY WAS DELAYED BY APPROXIMATELY 10 MINUTES.. CUP WAS LEFT IMPLANTED AND NO HOLE ELIMINATOR WAS IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 14955839 ↗
• InjuryJun 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PC WAS CREATED TO CAPTURES THE BLOOD CLOT THAT OCCURRED AFTER THE INITIAL SURGERY. DOI: (B)(6) 2019, DOR: (B)(6) 2021, RIGHT HIP.

  Patient problems: Embolism/Embolus

  MAUDE report 14565859 ↗
• InjuryMar 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 13929824 ↗
• InjuryJan 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TOTAL HIP REVISION FOR A PINNACLE LINER DISSOCIATION. LINER AND CUP WERE REMOVED AND REVISED TO DUAL MOBILITY CONSTRUCT. DOI: (B)(6) 2012, DOR: (B)(6) 2021, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Insufficient Information

  MAUDE report 13205473 ↗
• InjuryJun 22, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE CUP AT THE BONE TO IMPLANT INTERFACE. CAUSING INSTABILITY. DOI: (B)(6) 2021. DOR: (B)(6) 2021; LEFT HIP.

  Patient problems: Inadequate Osseointegration; Joint Laxity

  MAUDE report 12042641 ↗
• MalfunctionNov 20, 2020Difficult to Insert; Difficult to Insert

  AFTER CUP WAS IMPACTED INTO THE ACETABULUM, THE SURGEON ASKED FOR AN APEX HOLE ELIMINATOR. HE INSERTED THE HOLE ELIMINATOR INTO THE CUP AND IT WENT STRAIGHT THROUGH THE HOLE IN THE CUP, AND FELL OFF THE SCREWDRIVER BEHIND THE NEW ACETABULAR CUP. AFTER TELLING ME WHAT HAD HAPPENED, HE CONTINUED SURGERY AS NORMAL. THERE WAS A SLIGHT SURGICAL DELAY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 10875872 ↗
• InjurySep 1, 2020Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  DUE TO COVID LOCKDOWN, CASE WAS MADE AWARE OF A SUSPECTED FRACTURED DELTA CERAMIC LINER WITH A PATIENT 18 MONTHS POST OPERATION (THIS WOULD HAVE BEEN A VERY RARE EVENT IN RELATION TO DELTA CERAMICS) HAVING REQUESTED THE HOSPITAL LOOKED INTO THE PATIENTS NOTES IT WAS CONFIRMED THAT IT WAS A 48MM GRIPTION 100 PINNACLE SHELL ((B)(4)) WITH A ALTRX 48 X 32MM +4MM / 10 DEGREE LINER ((B)(4)) WE PREPARED FOR THE REMOVAL OF THE CUP, EXCHANGE OF THE LINER & BROUGHT IN DELTA TS CERAMIC HEADS FOR THE CASE. UPON ENTERING THE SURGICAL SITE, IT WAS CLEAR THAT THE LINER HAD FULLY DISENGAGED FROM THE CUP THE UPPER EDGE OF THE CUP HAD BROKEN AWAY FOR THE MAIN BODY & THE ARD (ANTI ROTATIONAL DEVICES) HAD WORN AWAY. THE SITE CONTAINED A SMALL AMOUNT OF METAL DEBRIS. THE LINER WAS RETRIEVED & THE SOCKET WAS FULLY CLEANED UP. UPON INSPECTING THE CUP IT WAS FELT IT WAS SITTING IN THE CORRECT POSITION & WAS SOLID, THERE APPEARED TO BE NO SIGN OF DAMAGE. A DECISION WAS MADE TO REPLACE THE LINER ONLY LEAVING THE CUP INTACT, A NEW HEAD WOULD BE PLACED ON THE STEM WHICH ALSO WAS TO REMAIN. A REPLACEMENT ALTRX 48 X 32 +4MM / 10 DEGREE LINER WAS PLACED IN SITU WITH A 32MM DELTA CERAMIC TS +5 HEAD.

  Patient problems: No Code Available

  MAUDE report 10476742 ↗
• InjuryOct 17, 2019Use of Device Problem; Loss of Osseointegration; Malposition of Device; Osseointegration Problem; Use of Device Problem; Loss of Osseointegration; Malposition of Device; Osseointegration Problem

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS RECURRENT DISLOCATION AND LOOSENING OF THE ACETABULAR COMPONENT. PATIENT PREVIOUSLY HAD A CLOSED REDUCTION PROCEDURE ON (B)(6) 2019. INTRAOPERATIVELY, THERE WAS A HEMOLYZED HEMATOMA WHICH WAS IRRIGATED AND WASHED FREE. THE ENTIRE POSTERIOR CAPSULE AND SHORT EXTERNAL ROTATORS HAD BEEN DAMAGED FROM THE DISLOCATION. THE ACETABULAR COMPONENT WAS NOTED TO HAD FLATTENED OUT AND WAS ALMOST RETROVERTED AND FLAT IN THE NEUTRAL POSITION. DOI: (B)(6) 2010; DOR: (B)(6) 2010 (LEFT HIP).

  Patient problems: Hematoma; Inadequate Osseointegration; No Code Available

  MAUDE report 9203729 ↗
• InjuryApr 3, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT IT WAS THE REVISION OF THE ACETABULAR CUP, SURGEON BELIEVE THAT THE ORIGINAL CUP WAS TOO VERTICAL. DOI: (B)(6) 2014, DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 8479828 ↗
• MalfunctionDec 14, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SIZE 48 PINNACLE GRIPTION100 SHELL WOULD NOT UNSCREW/ DISENGAGE FROM CUP IMPACTOR HANDLE.

  Patient problems: Not Applicable

  MAUDE report 8164033 ↗
• InjurySep 24, 2018Malposition of Device; Malposition of Device

  PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Not Applicable

  MAUDE report 7901629 ↗
• InjurySep 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED DUE TO INSTABILITY. THE SURGEON EXPLANTED A DEPUY CUP AND LINER AND IMPLANTED A ZIMMER/BIOMET DUAL MOBILITY WITH A DEPUY HEAD. DOI: UNKNOWN; DOR: AUG 13, 2018; RIGHT HIP.

  Patient problems: Not Applicable

  MAUDE report 7851218 ↗
• InjuryMar 20, 2018Loss of Osseointegration; Loss of Osseointegration

  PATIENT WAS REVISED TO ADDRESS POSSIBLE LOOSENING OF THE CUP AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2016; DOR: (B)(6) 2018 LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7352317 ↗