PINNACLE POROCOAT 1217-22-058Recalls & reported problems

Summary

The FDA's MAUDE database contains 142 adverse event reports that list this exact device (DI 10603295009856), received between Sep 14, 2017 and Sep 10, 2026 — classified as 3 deaths, 133 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (23 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 142 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Device Dislodged or Dislocated

  It was reported that the patient presented acutely at ED on 17/8/26 unable to weight-bear on right side 10 years post THA following a deep flexion movement (no fall). The patient was taken to theatre on 19/8/26 and revision of liner and head was performed. A 56 x 36 lipped ALTRX liner was implanted and a 1.5mm Delta TS head. The surgeon was confident there was no damage to inner surface of cup insitu and decided to leave in place.

  Patient problems: Loss of Range of Motion

  MAUDE report 50713383 ↗
• InjuryApr 21, 2026Fracture; Osseointegration Problem

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2026. DARTHMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: LOOSENING OF THE CUP AT THE BONE TO IMPLANT INTERFACE. EXPLANT ANALYSIS IDENTIFIED FRACTURE OF THE POROUS COATING OF THE CUP, WEAR AND YELLOWING OF THE ACTABULAR LINER, WEAR OF THE FEMORAL HEAD.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24940735 ↗
• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6) STUDY NO: OASIS PROD. CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ INFECTION DEVICE AND PROCEDURE (RELATEDNESS) DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: 17 OCT 2025, DATE OF IMPLANT: (B)(6) 2025, DATE OF REVISION: (B)(6) 2025, DEVICE LOCATION: LEFT. TREATMENT/IMPACT: COMPONENTS REMOVED (STEM, HEAD, LINER, SHELL). DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 121722058 LOT NUMBER: M9551X COMPONENT TYPE: SHELL DESCRIPTION: PINNACLE SHELL SECTOR 58MM. CATALOG NUMBER: 136540730 LOT NUMBER: 4549269 COMPONENT TYPE: HEAD DESCRIPTION: BIOLOX DELTA REVISION HEAD 12/14 40MM +8.5. CATALOG NUMBER: 101012070 LOT NUMBER: 4724370 COMPONENT TYPE: STEM DESCRIPTION: ACTIS COLLARED HIGH OFFSET FEMORAL STEM SZ 7 . CATALOG NUMBER: 122140058 LOT NUMBER: M9976F COMPONENT TYPE: LINER DESCRIPTION: PINNACLE ALTRX 58MM X 40MM NEUTRAL. CATALOG NUMBER: 121730500 LOT NUMBER: PU236738 COMPONENT TYPE: SCREW DESCRIPTION: CANCELLOUS BONE SCREW 30MM.

  Patient problems: Unspecified Infection

  MAUDE report 23534019 ↗
• InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT WAS REVISED FOR A TOTAL HIP REPLACEMENT DUE CHRONIC INFECTION. ORIGINAL OPERATION FOR THE THR WAS ON AN UNKNOWN DATE IN 2018. ALL IMPLANTS WERE REMOVED AND STRYKER CEMENTED IMPLANTS IMPLANTED DUE TO INFECTION. ALL IMPLANTS WERE WELL FIXED WITH SIGNS ON BONE INTEGRATION AND ON GROWTH. NO FURTHER PATIENT CONSEQUENCES

  Patient problems: Unspecified Infection

  MAUDE report 22834122 ↗
• InjuryMay 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISASSOCIATED LINER AND THREE SCREWS OF UNDETERMINED LENGTH WERE ALSO REMOVED. PRIMARY SURGERY WAS PERFORMED ABOUT 10 YEARS AGO. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 21971591 ↗
• InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED INFECTION APPROXIMATELY TWO MONTHS POSTOP. THEY REMOVED ALL COMPONENTS AND IMPLANTED CEMENT SPACERS. DOI: UNKNOWN. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21160048 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT : WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO.

  Patient problems: Unspecified Infection

  MAUDE report 20735905 ↗
• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE MOM MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS METALLOSIS, HIP PAIN AND LIMITED ADL. OPERATIVE NOTE REPORTED. THERE WAS A SMALL AMOUNT OF MILDLY CLOUDY FLUID NOTED ON ENTRY TO THE HIP JOINT, SCAR TISSUE IN THE HIP JOINT WITH MILD EVIDENCE TO GRAY STAINING FROM METAL DEBRIS. THERE WAS A SMALL AMOUNT OF TISSUE AROUND THE LINER WITHIN THE CUP. HEAD AND LINER REVISION. CLINICAL VISIT ON (B)(6) 2023 HAD IMPRESSION OF OSTEOLYSIS, BURSITIS OR TENDINITIS DOI: ON (B)(6) 2008; DOR: ON (B)(6) 2023; RIGHT HIP.

  Patient problems: Adhesion(s); Foreign Body Reaction; Inflammation; Loss of Range of Motion; Muscle/Tendon Damage; Osteolysis; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 19919244 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION RECORDS AD 3&4 AUG 2023 ALLEGES ON JUNE 18, 2021, THE DEPUY CORAIL® STEM AT THE NECK ON THE PATIENT'S RIGHT HIP, WITHOUT WARNING, SUDDENLY AND CATASTROPHICALLY FRACTURED AT THE NECK WHILE PATIENT WAS SIMPLY WALKING. PATIENT SUFFERED SIGNIFICANT DAMAGES INCLUDING, BUT NOT LIMITED TO PHYSICAL INJURY, ECONOMIC LOSS, PAIN AND SUFFERING, AND WILL CONTINUE TO SUFFER DAMAGES INTO THE FORESEEABLE FUTURE. DOI: (B)(6) 2011. DOE: JUN 18, 2021. DOR: (B)(6) 2021. AFFECTED SIDE: RIGHT HIP. THIS PC WAS RE-OPENED DUE TO ADDITIONAL INFORMATION RECEIVED FROM (B)(6) ON 3 JUL 2024.

  Patient problems: Joint Laxity; Loss of Range of Motion; Numbness; Pain

  MAUDE report 19712674 ↗
• InjurySep 28, 2023Use of Device Problem; Use of Device Problem

  REVISION OF PINNACLE/ACTIS CONSTRUCT FOR INSTABILITY. PINNACLE CUP AND LINER WERE EXPLANTED. BIMENTUM CUP WAS IMPLANTED. DOI: (B)(6) 2022, DOE: (B)(6) 2023, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 17833243 ↗
• InjurySep 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO DEEP INFECTION. DID A WASHOUT AND IMMEDIATE EXCHANGE. DOI: (B)(6) 2023 AND DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17805294 ↗
• InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A DEEP INFECTION. DID A WASHOUT AND IMMEDIATE EXCHANGE. DOI- (B)(6) 2023 DOR- (B)(6) 2023 AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17740884 ↗
• MalfunctionJul 30, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE IMPLANT WOULD NOT STICK. OPENED ANOTHER 58 CUP AND IT STUCK. NOTHING WAS BROKEN. THERE WAS NO SURGICAL DELAY. NO FRAGMENTS WERE GENERATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17421705 ↗
• InjuryJul 7, 2023Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS, CLINICAL VISIT REPORTED CONSISTENT MOM DISEASE , PAIN AND LIMITED ADL, DIFFICULTY WALKING AND MUSCLE WEAKNESS AFTER FIRST REVISION OF THE LEFT HIP. DOI: (B)(6) 2020; DOR: UNREVISED; LEFT HIP.

  Patient problems: Ambulation or Postural Difficulties; Fatigue; Joint Laxity; Muscle/Tendon Damage; Necrosis; Pain; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 17280077 ↗
• InjuryMar 21, 2023Use of Device Problem; Use of Device Problem

  PATIENT REQUEST: I AM LOOKING TO SPEAK TO SOMEONE ABOUT MY RECENT HIP REVISION SURGERY TO REMOVE THE DEPUY ASR ITEM. ON 2-MAR-2023: SPOKE WITH PATIENT VIA PHONE. HE INDICATED HIS RIGHT HIP WAS IMPLANT WITH ASR IN (B)(6) 2010 AND UNDERWENT A REVISION IN (B)(6) 2023 FOR PAIN, METALLOSIS, AND STEM LOOSENING. PATIENT IS SEEKING COMPENSATION FOR THE PAIN. PATIENT WILL BE EMAILED (WITHIN ECM) A CONTACT FOR COMPENSATION REQUEST. MEDICAL RECORDS. ON (B)(6) 2023 RIGHT METALLOSIS, FAILED ASR DEPUY SECONDARY TO METALLOSIS PATIENT WAS REVISED DUE TO INSULT WITH TRUNNIONOSIS WITH THE FAILED ASR. THE PATIENT HAD ELEVATED METAL LABS OF PSEUDOTUMOR. THE ACETABULAR COMPONENT WAS NEUTRAL INVERSION. THE FEMORAL STEM WAS COMPLETELY LOOSE AT LEAST EXPECTEDLY LOOSE PRIOR TO SURGERY. DOI: (B)(6) 2010; DOR: (B)(6) 2023 ; RIGHT HIP.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Metal Related Pathology; Pain

  MAUDE report 16581397 ↗
• InjuryMar 15, 2023Use of Device Problem; Use of Device Problem

  AFTER A REVIEW OF THE MEDICAL RECORD, THE PATIENT WAS REVISED DUE TO OSTEOLYSIS IN THE RIGHT GREATER TROCHANTER TAKEN FROM MRI & CT LAST (B)(6) 2020.

  Patient problems: Foreign Body Reaction; Loss of Range of Motion; Muscle/Tendon Damage; Muscular Rigidity; Osteolysis; Pain

  MAUDE report 16544641 ↗
• InjuryMar 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PATIENT HAD HIS RIGHT HIP REPLACED BY SURGEON WHERE HE HAD A SUMMIT PINNACLE CONSTRUCT IMPLANTED. THIS PATIENT BEGAN TO EXPERIENCE PAIN AND DISCOMFORT IN HIS RIGHT HIP AND FOLLOWED UP WITH SURGEON AND SURGEON SCHEDULED THIS PATIENT FOR AN I&D AS THE WOUND WAS SUSPICIOUS FOR AN INFECTION. DURING THE I&D THE ACETABULAR CUP, HIP BALL, AND LINER WERE EXPLANTED WHILE THE SUMMIT STEM WAS LEFT IN SITU. A THOROUGH IRRIGATION DEBRIDEMENT WAS DONE IN THE WOUND AND A NEW PINNACLE CUP, LINER, AND FEMORAL HEAD WAS IMPLANTED BACK IN. DO NOT HAVE LABS OR CONFIRMATION THAT THE WOUND IS INFECTED WITH A PARTICULAR PATHOGEN. I DO NOT HAVE PATIENT DEMOGRAPHIC¿S TO SHARE FOR REPORT. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Discomfort; Pain; Unspecified Infection

  MAUDE report 16459377 ↗
• MalfunctionFeb 28, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED REAMER DID NOT WORK PROPERLY RESULTING IN THE CUP NOT SEATING PROPERLY. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16455030 ↗
• InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. ALL COMPONENTS WERE REMOVED EXCEPT THE PROXIMAL SLEEVE. NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2023, AND AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16405834 ↗
• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR BLEED WITH LARGE HEMATOMA. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022. (RIGHT HIP). TREATMENT: NONE.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Swelling/ Edema

  MAUDE report 16086915 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, PATIENT REVISED DUE TO INFECTION. DOI: (B)(6) 2019; DOR: (B)(6) 2019 ; LEFT HIP 3RD COMPLAINT.

  Patient problems: Unspecified Infection

  MAUDE report 15633173 ↗
• InjuryJul 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LINER DISASSOCIATED FROM THE CUP. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 14955606 ↗
• InjuryMar 15, 2022Osseointegration Problem; Osseointegration Problem

  AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED WAS DUE TO SEPTIC RIGHT TOTAL HIP HAD FAILED CONSERVATIVE TREATMENT INCLUDING LAVAGE WITH COMPONENT RETENTION, LOOSENING OF THE ACETABULAR COMPONENT. THE PLATE ITSELF HAD FRACTURED AND IT WAS GROSSLY LOOSE WITH PURULENT FIBROUS TISSUE, SOME DRAINAGE PRESENT AND HAD BEEN OVERGROWN BY HETEROTOPIC BONE. THE ACETABULUM ITSELF WAS ERODED WITH SEVERAL SMALL AREAS OF FULL-THICKNESS PENETRATION, NECROTIC DEBRIS WAS NOTED IN THE FLOOR OF THE ACETABULUM. DOI: (B)(6) 2010 DOR: (B)(6) 2010 RIGHT HIP.

  Patient problems: Adhesion(s); Extraskeletal ossification; Inadequate Osseointegration; Necrosis; Pocket Erosion; Unspecified Infection

  MAUDE report 13769838 ↗
• InjuryDec 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EMERGENCY DEPARTMENT NOTES ON (B)(6) 2020 STATED THAT THE PATIENT FELL A MONTH AGO AND HAD PAIN IN THE RIGHT HIP THAT RADIATED TO THE RIGHT KNEE. DUE TO THE PAIN IN THE HIP, THE PATIENT HAD LIMITED ABILITY TO AMBULATE. THERE WERE NO ALLEGATIONS THAT ANY INVASIVE TREATMENT, NOR PERMANENT INJURY OCCURRED DUE TO THE FALL THIS TIME. THERE WERE NO FRACTURES AND NO ALLEGATIONS THAT DEPUY PRODUCTS MALFUNCTIONED IN ANY WAY.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bone Fracture(s); Distress; Extraskeletal ossification; Fall; Fatigue; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Joint Laxity; Loss of Range of Motion; Metal Related Pathology; Muscle/Tendon Damage; Necrosis; Numbness; Osteolysis; Pain; Physical Asymmetry; Pocket Erosion; Scar Tissue; Swelling/ Edema; Synovitis; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 13043933 ↗
• InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S HIP IS INFECTED SO THE SURGEON REMOVED ALL COMPONENTS AND PUT IN ANTIBIOTIC HIP SPACER. DOI: (B)(6) 2020, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 12925812 ↗