PINNACLE GRIPTION 1217-32-048Recalls & reported problems

Summary

The FDA's MAUDE database contains 135 adverse event reports that list this exact device (DI 10603295010289), received between Sep 15, 2017 and Jul 30, 2026 — classified as 117 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (20 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 135 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Device Dislodged or Dislocated

  It was reported that the patient underwent total left hip arthroplasty on (b)(6) 2022. Patient subsequently experienced hip pain after feeling a "pop". An X-ray revealed decentralization of the modular head relative to the acetabular components (cup/liner). Patient underwent hip revision surgery on (b)(6) 2026, during which the surgeon opted to use Competitor's acetabular implants and a modular head.

  Patient problems: Pain

  MAUDE report 50084270 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  Patient was revised due to infection.DOI: (b)(6) 2022.DOR: (b)(6) 2026.Affected Side: Right Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50009381 ↗
• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS HAVING DISCOMFORT AND IMPINGEMENT ISSUES, SO THE DOCTOR REVISED. NO KNOWN INFECTION PRESENT. NO DELAY IN SURGERY. DOI: (B)(6) 2017, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Discomfort; Joint Laxity

  MAUDE report 25382298 ↗
• InjuryApr 7, 2026Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT HAD HIP DONE ORIGINALLY ON (B)(6) 2020. PATIENT SUFFERED A DISLOCATION. DR. FELT THE PATIENTS CUP POSITION MAY BE THE CAUSE FOR DISLOCATION. THEY OPTED TO REVISE THE CUP TO A COMPETITOR ACETABULAR COMPONENT. TRIAL REDUCTION WAS PERFORMED WITH A NEW FEMORAL HEAD TRIAL AND THE HIP WAS FOUND TO BE STABLE. NEW TS CERAMIC FEMORAL HEAD WAS OPENED AND IMPLANTED. STABILITY OF THE HIP WAS CONFIRMED AND THE CLOSING PROCESS BEGAN. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. ACTIVITY LEVEL: YES, DOI: ON (B)(6) 2020, DOR: UNKNOWN, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 24805211 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6), 2024. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 24800568 ↗
• InjuryFeb 20, 2026Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT RETURNED FOR ANOTHER COMPONENT EXCHANGE. PATIENT HAD EXTENSIVE HEAD AND POLY WEAR A SECOND TIME. THE DOCTOR EXPLANTED CUP TO REPOSITION. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Insufficient Information

  MAUDE report 24399402 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION OCCURRED ON (B)(6) 2025 DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23744231 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH INFECTED HIP 2 + YEARS POST THA. ALL WELL FIXED COMPONENTS WERE REMOVED AND A PROSTALAC WAS PLACED WITH NO DELAY NOR PATIENT HARM. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23584187 ↗
• InjuryJul 21, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAD REVISION OF PINNACLE CUP FOR SUSPECTED LOOSENING. THERE WAS A PINNACLE CUP LOOSENING AT NON-CEMENTED INTERFACE. DOI: (B)(6) 2020, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22559658 ↗
• MalfunctionJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO WORN IMPLANTS. THERE WAS NO SURGICAL DELAY. ON (B)(6) 2024, THE PATIENT UNDERWENT A SUCCESSFUL LEFT TOTAL HIP ARTHROPLASTY USING DEPUY SYNTHES IMPLANTS. ON (B)(6) 2025, THE PATIENT HAS A FOLLOW-UP APPOINTMENT THAT STATES A FEW DAYS PRIOR, THE PATIENT NOTICED A SQUEAKING SOUND FOLLOWING BENDING AND INCREASED FLEXION OF THE LEFT HIP. THE PATIENT ALSO HAS PAIN WHEN LOADING THE JOINT. THE PATIENT LIMPS AND HAS AN ANTALGIC GAIT PATTERN. X-RAYS SHOW THE INSERT HAS WEAR ON THE LEFT SIDE CAUSING SUPERIOR MIGRATION OF THE HEAD.

  Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion; Pain

  MAUDE report 22480793 ↗
• MalfunctionJun 17, 2025Noise, Audible; Noise, Audible

  PATIENT UNDERWENT PRIMARY SURGERY ON (B)(6) 2022. DUE TO EARLY WEAR OF THE INSERT, REVISION WAS DONE (B)(6) 2023. AFTER THAT, PATIENT DID NOT EXPERIENCE ANY MAJOR ISSUES. HOWEVER, ON (B)(6) 2025, THEY STARTED EXPERIENCING SQUEAKING AFTER GETTING UP FROM THE DINNER TABLE. X-RAY SHOWED PROXIMAL MIGRATION OF THE HEAD IN THE SOCKET. SECOND REVISION AND INSERT EXCHANGE WAS DONE (B)(6) 2025. SINCE THE SECOND REVISION SURGERY, PATIENT IS SYMPTOM FREE; NO COMPLAINTS.

  Patient problems: Insufficient Information

  MAUDE report 22236455 ↗
• InjuryMay 8, 2025Naturally Worn; Naturally Worn

  ON (B)(6) 2022, THE PATIENT HAD LEFT TOTAL HIP ARTHROPLASTY. DEPUY COMPONENTS WERE IMPLANTED., INCLUDING 2 SCREWS. ON (B)(6) 2024, PATIENT REPORTS AUDIBLE SQUEAKING IN HIP, AND PAIN AT NIGHT AND SLIGHT LEG LENGTH DISCREPANCY. ON (B)(6) 2025, PATIENT HAD A LEFT HIP REVISION TO ADDRESS FAILED LEFT TOTAL HIP. DURING THE PROCEDURE THE SURGEON REPORTED THAT THERE WAS A NOTABLE QUANTITY OF FLUID IN HIP, THE FEMORAL HEAD WAS SIGNIFICANTLY WORN, AND THE POLYETHYLENE HEAD (LINER) WAS EXTRACTED IN NUMEROUS DIFFERENT PIECES AND APPEARED WORN. THERE WAS SYNOVITIS WITH METALLIC DEBRIS.

  Patient problems: Cellulitis; Pain; Physical Asymmetry; Swelling/ Edema; Synovitis

  MAUDE report 21984171 ↗
• InjuryApr 23, 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. SURGEON REMOVED ALL IMPLANTS AND REPLACED WITH TEMPORARY SPACER. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21892074 ↗
• InjuryApr 22, 2025Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT SINCE THE END OF (B)(6) 2024, THE PATIENT HAS NOTICED CREAKING IN THE OPERATED HIP IN THE FLEXION-EXTENSION POSITION. DURING REVISION SURGERY, THE INSERT WAS REPLACED BECAUSE IT WAS WORN OUT / FRAYED.. THERE WAS NO SURGICAL DELAY. IT WAS FURTHER REPORTED THAT METALLOSIS WAS FOUND WITHIN THE CAPSULE. THE FEMORAL STEM AND ACETABULAR CUP WERE FOUND TO BE WELL FIXED AND RETAINED.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 21881034 ↗
• InjuryMar 24, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT FELL AND THE ACETABULUM SHIFTED IN THE LEFT HIP. PATIENT WAS REVISED. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall

  MAUDE report 21676560 ↗
• MalfunctionFeb 19, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT A UNIT OF THE PRODUCT COPA PINNACLE GRIPTION SECTOR 48MM WAS RECEIVED WITHOUT THE TRACEABILITY LABEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21412347 ↗
• InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN OF TOTAL HIP ARTHROPLASTY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 21162577 ↗
• InjuryNov 25, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT UNDERWENT HIP REVISION SURGERY. THE PATIENT EXPERIENCED PAIN AS A RESULT OF THE INSERT SLIPPING OUT OF THE BEARING SHELL. AFTER THE PATIENT WAS OPENED DURING THE PROCEDURE, ADVANCED METALOSIS WAS PRESENT IN THE JOINT. THE OPERATION ENDED WITH A REVISION. THE BEARING SHELLS, THE INSERTS AND THE REPLACEMENT OF THE HEAD ON THE FEMUR STEM. ELEMENTS WERE REMOVED FROM THE PATIENT'S BODY AND INTRAOPERATIVE IMAGES WERE TAKEN. THE SWAB WAS TAKEN FOR LABORATORY EXAMINATION.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 20770804 ↗
• InjuryNov 20, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LINER DISASSOCIATION FROM CUP. CUP, SCREW, AND STEM REMAINED IN THE PATIENT. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20735475 ↗
• InjuryNov 19, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED, THAT THE ORIGINAL CUP FAILED, DUE TO FIBROUS INGROWTH. THERE WAS LOOSENING OF THE PINNACLE GRIPING CUP AT THE UNCEMENTED INTERFACE. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20726798 ↗
• InjuryNov 5, 2024Use of Device Problem; Osseointegration Problem; Use of Device Problem; Osseointegration Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE CUP WAS NOT MISALIGNED. THE PATIENT DID EXPERIENCE HIP PAIN EARLY ON. POSSIBLY FROM LENGTH DISCREPANCY OR THE CUP DID NOT FULLY GROW IN. IT DID APPEAR TO HAVE JUST FIBROUS INGROWTH INSTEAD OF GOOD BONE GROWTH AND THE PROBLEM OCCURRED OVER TIME. NO REPORTED SURGICAL DELAY.

  Patient problems: Inadequate Osseointegration; Pain; Physical Asymmetry

  MAUDE report 20613026 ↗
• InjuryOct 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PINNACLE ALTRX POLYETHYLENE WAS DISENGAGED FROM ACETABULAR SHELL AND WORN ALONG RIM. BIOLOX DELTA CERAMIC FEMORAL HEAD SURFACE WAS WORN FROM CONTACT WITH ACETABULAR SHELL. APEX HOLE ELIMINATOR WAS REMOVED TO ALLOW ABILITY TO TRIAL. DOI: (B)(6) 2021, DOR: (B)(6) 2024 AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 20382132 ↗
• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE REMOVAL OF PINNACLE GRIPTION 48 MM CUP,32-48 +4 NEUTRAL LINER, APEX HOLE ELIMINATOR, PINNACLE SCREW 6.5 30MM, AND ARTICUL/EZE FEMORAL HEAD 32+1 PERFORMED DUE TO INSTABILITY. THERE WAS NO SURGICAL DELAY IN THE CASE, AND NO INFORMATION WAS PROVIDED OF WHEN IMPLANTATION OCCURRED. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: UNKNOWN HIP SIDE.

  Patient problems: Joint Laxity

  MAUDE report 20345054 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS NO SURGICAL DELAY. THE AFFECTED SIDE WAS THE RIGHT.

  Patient problems: Joint Laxity

  MAUDE report 20181458 ↗
• InjuryAug 21, 2024Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF CUP AT UNKNOWN INTERFACE. THERE WAS ALSO FRACTURE TO MEDIAL WALL. DOI: UNKNOWN. DOR: ON (B)(6) 2024. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 20016243 ↗