PINNACLE GRIPTION 1217-30-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295009979), received between Jun 23, 2017 and Jan 7, 2026 — classified as 23 injuries, 1 malfunction.

The most frequently reported specific device problem is “Osseointegration Problem” (5 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ITEMS EXPLANTED DUE TO UNSTABLE CUP. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Laxity

  MAUDE report 23996927 ↗
• InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED EXPLANTED / DUE TO INFECTION. DOI: UNKNOWN DOR: UNKNOWN AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21656548 ↗
• InjuryOct 30, 2024Osseointegration Problem; Migration; Osseointegration Problem; Migration

  PATIENT PRESENTED IN OFFICE WITH POST OP HIP PAIN. UPON FURTHER ANALYSIS AND XRAY IT WAS FOUND THAT THE CUP HAD LOOSENED AND BECOME VERTICAL. A PLAN WAS THEN IN PLACE TO EXPLANT THE CUP, LINER, HEAD AND SCREWS. ACETABULUM WAS RE REAMED AND A NEW CUP, LINER, HEAD, AND SCREWS WERE IMPLEMENTED. DOI: (B)(6) 2024 DOR: (B)(6) 2024 AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 20568369 ↗
• InjuryDec 20, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT CUP DID NOT GROW INTO THE ACETABULUM. SURGICAL DELAY UNKNOWN. DOE: (B)(6) 2023. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18365654 ↗
• InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. ON (B)(6) 2013 CONSULTATION REPORT STATED PATIENT PLANS TO HAVE A RIGHT TOTAL HIP ARTHROPLASTY ON MAY 6 DUE TO PROGRESSIVE OSTEOARTHRITIS (NO PC REQUIRED). ON (B)(6) 2020 MRI WAS REPORTED TO SHOW LEFT HIP JOINT EFFUSION AND SYNOVITIS WITH PSEUDOCAPSULE DEHISCING INTO THE TROCHANTERIC BURSA . FEBRUARY 28TH NOTE INCREASED COBALT 6.6 AND CHROMIUM 7.1. (PAGE 1382 OF 6668). ON (B)(6) 2021 THE PATIENT HAD A LEFT HIP REVISION TO ADDRESS OSTEOLYSIS, ELEVATED METAL ION LEVELS, PAIN, CREPITUS, AND METALLOSIS. THE SURGEON OBSERVED THAT THE ABDUCTORS AND BONE WERE NECROTIC THERE WAS CORROSION NOTED ON THE FEMORAL HEAD AS WELL AS THE TRUNNION. THE TRUNNION WAS CLEANED OFF. A DEPUY PINNACLE CONSTRAINED +4 LINER, AND A 28+ 0 BIOLOX DELTA CERAMIC FEMORAL HEAD WERE IMPLANTED DURING THIS PROCEDURE. (SURGERY PAGE 1333 OF 6668). ON (B)(6) 2021 PATIENT NOTES REDNESS AND ITCHINESS AROUND THE INCISION SITE. ON (B)(6) 2022 PATIENT HAD A LEFT HIP REVISION TO ADDRESS DISLOCATION AND PAIN. DURING THE PROCEDURE, THE SURGEON OBSERVED SIGNIFICANT EVIDENCE OF RESIDUAL METAL DEBRIS AND THERE WAS CLEARLY EVIDENCE OF POLYETHYLENE WEAR. IT WAS NOTED THAT THERE WAS EVIDENCE OF WEAR ON THE CE

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Deformity/ Disfigurement; Foreign Body Reaction; Loss of Range of Motion; Necrosis; Osteolysis; Scar Tissue; Swelling/ Edema; Synovitis; Unspecified Musculoskeletal problem; Unspecified Tissue Injury

  MAUDE report 16544489 ↗
• InjuryFeb 16, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT THE SURGERY VIA THA WITH THE CUP IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE CUP HAS BEEN LOOSENED. THE REVISION SURGERY IS PLANNED ON (B)(6) 2023. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16385015 ↗
• 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 15384411 ↗
• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HIP REPRESENTED INFECTION AGAIN AFTER 6+ WEEKS. PATIENT WAS REVISED AND PULLED OUT ALL EXISTING IMPLANTS AND REPLACED WITH PROSTALAC SPACER. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 14212671 ↗
• InjuryJan 7, 2022Use of Device Problem; Use of Device Problem

  THE SURGEON STATED THAT THE CUP WAS NOT POSITIONED WELL AND LOOKED EXTREMELY OFF RADIOGRAPHICALLY. UPON OPENING THE HIP, THE SURGEON FOUND THE HEAD NOT INSIDE OF THE CONSTRAINED LINER BECAUSE THERE WAS NO LOCKING RING IN PLACE. SURGEON STATED THAT THE STEM WAS WELL FIXED AND JUST ELECTED TO REVISE THE ACETABULAR SHELL. DOI: (B)(6) 2021; DOR: (B)(6) 2021; RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 13191044 ↗
• InjuryNov 15, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE CUP AT THE BONE TO IMPLANT INTERFACE. LOOSE CUP WAS DUE TO PATIENT NOT FOLLOWING PROTOCOL. REPLACED CUP, LINER, SCREWS AND HEAD WITH REVISION COMPONENTS. DOI: (B)(6) 2021; DOR: (B)(6) 2021; AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12813910 ↗
• InjuryNov 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT HAD CHRONIC PAIN, DISCOMFORT, ABDOMINAL DISTENTION, MUSCLE WEAKNESS, DIFFICULTY WALKING, URINARY RETENTION AND LIMITED RANGE OF MOTION POST REVISION. DOI: (B)(6), 2017, DOR: UNKNOWN, LEFT HIP.

  Patient problems: Abdominal Distention; Ambulation or Postural Difficulties; Discomfort; Fatigue; Loss of Range of Motion; Pain; Urinary Retention

  MAUDE report 12758996 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTION. THE PATIENT WENT THROUGH SEVERAL I&DS AND WOULD NOT GET BETTER. THE SURGEON DECIDED TO DO A HIP DISARTICULATION. THE STEM, LINER AND CUP HAD TO COME OUT. THERE WERE NO INSTRUMENTS BROKEN OR DAMAGED. ALL COMPONENTS WERE REMOVED. DOI: (B)(6) 2021. DOR: (B)(6) 2021. (LEFT HIP).

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

  MAUDE report 12517278 ↗
• InjuryJun 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A PAINFUL TOTAL HIP, SURGEON ELECTED TO REVISE THE CUP TO A COMPETITOR AND EXCHANGE THE HEAD. DOI: (B)(6) 2009; DOR: (B)(6) 2021; AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 12009059 ↗
• InjuryJan 11, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE ACETABULAR CUP AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2015; DOR: (B)(6) 2020: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11148687 ↗
• InjuryJun 11, 2020Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL LOOSENING OF ACETABULAR COMPONENTS AND AUGMENT AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2015, DOR: (B)(6) 2020, AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 10145673 ↗
• InjuryDec 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR FOOT DROP.

  Patient problems: No Code Available

  MAUDE report 8129734 ↗
• InjuryNov 30, 2018Fracture; Fracture

  CLINICAL ADVERSE EVENT RECEIVED FOR INTRA-OPERATIVE ACETABULAR FRACTURE - PELVIC.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 8119429 ↗
• InjuryNov 19, 2018Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  REVISION DUE TO DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 8085947 ↗
• InjuryMay 31, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION DUE TO PAIN.

  Patient problems: Not Applicable; Pain

  MAUDE report 7556518 ↗
• InjuryMay 25, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  THE PATIENT WAS REVISED TO ADDRESS RIGHT HIP PAIN. IT WAS ALSO INDICATED THAT ASPIRATION WAS POSITIVE FOR INFECTION, AND LOOSENING OF THE ACETABULAR CUP AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2013; DOR: (B)(6) 2018; RIGHT HIP. NO SURGICAL DELAY.

  Patient problems: Inadequate Osseointegration; Not Applicable; Pain; Unspecified Infection

  MAUDE report 7544971 ↗
• InjuryMay 21, 2018Disassembly; Disassembly

  DER STATES PATIENT UNDERWENT A DIFFICULT PRIMARY TOTAL HIP BACK IN (B)(6) 2017 WHERE A REVISION MULTIHOLE PINNACLE CUP WAS IMPLANTED. THE PATIENT HAD A LARGE CYST/DEFECT IN HIS ACETABULUM REQUIRING LARGE AMOUNTS OF BONE GRAFTS AND SCREWS. A PINNACLE ALTRX +4/10 DEGREE WAS IMPLANTED ALONG WITH SUMMIT STEM AND A 32+1 HEAD. ALL COMPONENTS WERE VERY GOOD CHOICE FOR THIS PATIENT. A FEW MONTHS LATER PATIENT COMPLAINED OF PAINFUL HIP REVISION SURGERY WAS REQUIRED. UPON INSPECTION INTRAOPERATIVELY IT SEEMED THE LINER HAD NOT FULLY LOCKED INTO PINNACLE CUP. A NEW LINER WAS PLACED ALONG WITH A NEW HEAD. FIXATION OF LINER WAS THOROUGHLY INSPECTED AND LOCKED PROPERLY INTO CUP. DOI: (B)(6) 2017; DOR: (B)(6) 2018; UNKNOWN HIP.

  Patient problems: Not Applicable; Pain

  MAUDE report 7530259 ↗
• InjuryFeb 28, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  PATIENT COMPLAINED OF PAIN, XRAY SHOWS LOSS OF FIXATION OF ACETABULAR COMPONENT. REMOVED CUP, LINER, HEAD AND TWO BONE SCREWS. IMPLANT FRACTURE OF TWO BONE SCREWS.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 7302597 ↗
• InjuryAug 23, 2017Disassembly; Disassembly

  THE PATIENT WAS REVISED TO ADDRESS CUP AND ALTRX LINER THAT HAD DISASSOCIATED ITSELF FROM THE SHELL.

  Patient problems: No Information

  MAUDE report 6814796 ↗
• InjuryJun 23, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS UNRECOGNIZED PELVIC FRACTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 6663078 ↗