PINNACLE POROCOAT 1217-03-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10603295008644), received between Aug 18, 2017 and May 16, 2025 — classified as 29 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (6 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 29 reports, in the reporter's own words as published by the FDA.

• InjuryMay 16, 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 FRACTURED CERAMIC HEAD. NO KNOWN FALL, ETC. LARGE FRAGMENTS RETRIEVED. UNKNOWN QUANTITY OF FRAGMENTS RETAINED. SHELL REVISED TO INCREASE HIP STABILITY. LINER DAMAGE BY HEAD FRACTURE AND TRUNION CONTACT. DOI: (B)(6) 2013. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 22039488 ↗
• InjurySep 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2012, PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY DUE TO DEGENERATIVE JOINT DISEASE. ON (B)(6) 2023, PATIENT UNDERWENT A REVISION DUE TO PAIN AND LOSS OF FUNCTION SECONDARY TO METALLOSIS.

  Patient problems: Foreign Body Reaction; Loss of Range of Motion; Pain

  MAUDE report 20334635 ↗
• InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO EXPERIENCING SOME HIP PAIN, SURGEON ELECTED TO REVISE THE CUP AND CONVERT TO A CERAMIC ON POLY CONSTRUCT. PATIENT HAD A MOM LINER THAT WAS A 36X50MM THAT WAS UNABLE TO FIND THE PART NUMBER FOR. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 19089935 ↗
• InjurySep 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED EVENT DESCRIPTION: THE PATIENT PRESENTS ABDOMINAL PAIN, DIARRHEA, AND PAIN IN HER LEGS. SHE HAS A HISTORY OF BOTH VENOUS AND ARTERIAL CLOTS IN HER RIGHT LEG AND STATES HER LEFT LEG FELT COLD AND WAS PAINFUL TO MOVE WHEN SHE GOT UP TO USE THE BATHROOM. SHE DOES HAVE PARTIAL PARALYSIS OF THE RIGHT LEG DUE TO A FAILED HIP REPLACEMENT IN NY 5-6 YEARS AGO. DENIES VOMITING, FEVER, AND CHILLS. SHE IS ON PLAVIX AND XARELTO. DENIES BACK PAIN.

  Patient problems: Balance Problems; Fatigue; Fibrosis; Foreign Body Reaction; Granuloma; Hematoma; Hypersensitivity/Allergic reaction; Inflammation; Loss of Range of Motion; Metal Related Pathology; Muscular Rigidity; Necrosis; Nerve Damage; Numbness; Pain; Paralysis; Paresthesia; Swelling/ Edema; Thrombosis/Thrombus; Unspecified Infection; Unspecified Nervous System Problem; Unspecified Tissue Injury

  MAUDE report 17788597 ↗
• InjuryOct 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD REMOVAL OF CUP AND HEAD DUE TO WANTING TO CHANGE THE CUP PLACEMENT. NO MORE INFO AVAILABLE. NO LOOSENING AND NO SURGICAL DELAY WAS THERE. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 15523142 ↗
• InjurySep 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORD RECEIVED. PATIENT WAS IMPLANTED WITH PINNACLE CUP AND METAL HEAD AND LINER LAST 2009 AND USING A DEPUY SUMMIT HIP SYSTEM. PATIENT EXPERIENCED PAIN, METALLOSIS, ELEVATED METAL ION, PSEUDOTUMORS, SWELLING, METAL DEBRIS, DIFFICULTY AMBULATION, STIFFNESS, BEEN CONSTIPATED SINCE THE SURGICAL PROCEDURE, DIFFICULTY TRANSFERRING AS WELL AS DOING ADLS, IMPAIRED ROM, IMPAIRED GAIT, BURSITIS, DECREASED LUMBAR MOBILITY, FLEXIBILITY, AND WEAKNESS. PATIENT HAD SIGNIFICANT BONE LOSS FROM TROCHANTERIC REGION OF FEMUR, AS WELL AS AROUND PORTIONS OF THE ACETABULUM. REVISION NOTES STATED THAT A BLACK GELATINOUS MATERIAL WAS ENCOUNTERED UPON ENTERING THE HIP JOINT AND ALVAL LESIONS WERE DEEP TO THE ACETABULAR IMPLANT. CUP, HEAD, AND LINER WERE REMOVED DURING THE FIRST REVISION OF THE LEFT HIP. LEFT (B)(6) 2009 - DOR: (B)(6) 2021 (LEFT HIP).

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Extraskeletal ossification; Fatigue; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Loss of Range of Motion; Muscular Rigidity; Necrosis; Osteolysis; Pain; Swelling/ Edema; Synovitis; Unspecified Tissue Injury

  MAUDE report 15517143 ↗
• InjuryOct 21, 2020Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT HAD PAIN DUE TO CHRONIC DISLOCATION. CUP MALPOSITIONED. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2020, LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10711399 ↗
• InjuryJun 17, 2020Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS LOOSE CUP AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2020. DOR: (B)(6) 2020; LEFT SIDE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 10162986 ↗
• InjuryMar 30, 2020Malposition of Device; Malposition of Device

  LITIGATION ALLEGES THAT PATIENT EXPERIENCED PAIN, WEAKNESS, DIFFICULTY WITH SIMPLE DAILY LIVING ACTIVITIES, INABILITY TO RETURN TO WORK, AND INCREASED METALLIC IONS IN HIS BLOODSTREAM. REVISION OPERATIVE NOTE REVIEWED AND CONFIRMED METALLOSIS. THE REVISION OPERATIVE NOTE ALSO MENTIONS ALVAL. IN ADDITION TO WHAT PREVIOUSLY ALLEGED, LITIGATION ALLEGED METAL WEAR, SKIN RASHES, WEIGHT LOSS, PAIN, INCREASE INCIDENCE OF ATRIAL FIBRILLATION, ANXIETY, THIRST, LOOSE OF TASTE, METALLIC TASTE IN SALIVA, AND DRY FRAGILE SKIN. AFTER REVIEW OF MEDICAL RECORDS IT WAS INDICATED THAT THE PATIENT PRESENT WITH PROGRESSIVE WORSENING LEFT HIP PAIN, DEMONSTRATED ELEVATED METAL IONS. THE PATIENT WAS THEN REVISED FOR PAINFUL METAL-SENSITIVITY REACTION TO NECROSIS (ALVAL). OPERATIVE NOTES REPORTED THAT THE CUP WAS LITTLE GENEROUSLY ANTEVERTED AND THERE WAS SOME EROSIVE DEFICIENCY NOTED OF THE ANTERIOR ACETABULAR BONY WALL, DUE TO INFLAMMATORY PROCESS.

  Patient problems: Anxiety; Atrial Fibrillation; Discomfort; Foreign Body Reaction; Inflammation; No Code Available; Pain; Polydipsia; Rash; Test Result; Weakness

  MAUDE report 9899671 ↗
• InjuryAug 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS ALLEGES PAIN IN FEMUR, WEAK, FATIGUE, WALKING DIFFICULTY, STIFF BONE, LIMITED ADL, EXCESSIVE TOXIC LEVELS OF METAL IONS IN THE BLOOD, METALLOSIS IN THE RIGHT HIP AND TISSUE. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS METALLOSIS POST MOM THA, PAIN, ELEVATED METAL IONS, FLUID COLLECTION ON MRI. OPERATIVE NOTE REPORTED SOME BLOOD TINGED FLUID, METALLOSIS, OSTEOLYSIS, MINIMAL BONE LOSS. OPERATIVE NOTES (B)(6) 2019 INDICATE THE PATIENT RECEIVED A REVISION OF THE RIGHT TOTAL HIP DUE TO INCREASING METAL ION LEVELS, PAIN, AND MRI RESULT OF FLUID COLLECTION. UPON ENTERING THE JOINT, SLIGHT OSTEOLYSIS, METALLOSIS AND TRUNNIONS WAS NOTED, THE JOINT WAS DEBRIDED. HEAD, LINER, AND CUP REVISED. PROCEDURE WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6) 2009 . DOR: (B)(6) 2019. RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fatigue; Foreign Body Reaction; Loss of Range of Motion; Metal Related Pathology; Muscular Rigidity; No Code Available; Osteolysis; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 8941428 ↗
• InjuryApr 12, 2019Osseointegration Problem; Osseointegration Problem

  PPF ALLEGES LOOSENING OF THE CUP, METAL WEAR, METALLOSIS, AND ELEVATED METAL IONS. DOI: (B)(6) 2008 - DOR: (B)(6) 2013, (RIGHT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; Pain; Swelling; Tissue Damage

  MAUDE report 8508671 ↗
• InjuryApr 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS SUBSEQUENT INFECTION. ALL IMPLANTS WERE EXPLANTED AND A PROSTALAC ANTIBIOTIC SPACER WAS IMPLANTED. DOI: (B)(6) 2019. DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8482750 ↗
• InjuryApr 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL ION PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE, AND BONE. UPDATE AD 17 JUL 2018: RECEIPT OF PPF AND STICKER SHEETS RECORD. IN ADDITION TO PREVIOUS ALLEGATIONS, PPF ALLEGES DISLOCATION AND INFECTION. UPDATED PART AND LOT NUMBERS OF UNKNOWN HEAD AND LINER. STEM, SLEEVE, CUP AND APEX HOLE ELIMINATOR WERE ADDED DUE TO ALLEGED INFECTION.

  Patient problems: Discomfort; Inflammation; No Code Available; Pain; Unspecified Infection

  MAUDE report 8477762 ↗
• InjuryMar 29, 2019Use of Device Problem; Use of Device Problem

  PPF ALLEGES DISLOCATION AFTER FIRST REVISION. UPDATE: PFS ALLEGES METAL POISONING. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESS OSTEOARTHRITIS LEFT HIP. DOI: (B)(6) 2016 - DOR: (B)(6) 2017 (LEFT HIP). SEE (B)(4) FOR THE FIRST REVISION LEFT HIP.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 8465560 ↗
• InjuryMar 28, 2019Osseointegration Problem; Osseointegration Problem

  PPF ALLEGES LOOSENING OF CUP. DOI: (B)(6) 2009 - DOR: (B)(6) 2009 - (LEFT HIP).

  Patient problems: Inadequate Osseointegration; Inflammation; Limited Mobility Of The Implanted Joint; Pain; Pocket Erosion; Swelling

  MAUDE report 8459409 ↗
• InjuryFeb 27, 2019Loss of Osseointegration; Loss of Osseointegration

  PPF ALLEGES LOOSENING OF CUP AND METAL WEAR/METALLOSIS.

  Patient problems: Inadequate Osseointegration; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Tissue Damage

  MAUDE report 8375459 ↗
• InjuryJan 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION DUE TO PAIN.

  Patient problems: Failure of Implant; No Code Available; Pain

  MAUDE report 8252981 ↗
• InjuryDec 18, 2018Loss of Osseointegration; Malposition of Device; Loss of Osseointegration; Malposition of Device

  FTER REVIEW OF MEDICAL RECORDS, IT WAS INDICATED THAT THE PATIENT HAS BEEN COMPLAINING OF PAIN. PHYSICIAN NOTES REPORTED THAT THE ACETABULAR COMPONENT WITH QUESTIONABLE LOOSENING. CUP IS VERTICAL WITH MOM BEARING PLACING IT AT HIGH RISK FOR METALLOSIS/PSUEDOTUMOR. SHE HAS MECHANICAL SYMPTOMS. ADDITIONAL VISIT NOTES REPORTED THAT THE CUP APPEARS AS THOUGH IT MAY BE LOOSE, HOWEVER HAS NOT MOVED OR MIGRATED. SHE DOES HAVE A MOM HIP WITH MILDLY ELEVATED METAL IONS.

  Patient problems: Discomfort; Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8173457 ↗
• InjuryDec 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8168825 ↗
• InjuryOct 26, 2018Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE ACETABULAR CUP AT THE BONE TO IMPLANT INTERFACE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8009296 ↗
• InjuryOct 17, 2018Failure to Osseointegrate; Failure to Osseointegrate

  PENDING PRODUCT LIABILITY, CUSTOMER ALLEGES LOOSENING OF CUP AFTER FIRST REVISION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7975415 ↗
• InjuryOct 5, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PATIENT WAS REVISED TO ADDRESS HIP PAIN IN HER RIGHT HIP.

  Patient problems: Not Applicable; Pain; Tissue Damage

  MAUDE report 7939960 ↗
• InjuryJun 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2016; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Pain

  MAUDE report 7633425 ↗
• InjuryJun 5, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY DUE TO DISLOCATED HIP. IT WAS ALSO INDICATED THAT THE CUP WAS GROSSLY LOOSE AT BONE TO IMPLANT INTERFACE. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Not Applicable

  MAUDE report 7568662 ↗
• InjuryFeb 20, 2018Disassembly; Device Dislodged or Dislocated; Noise, Audible; Disassembly; Device Dislodged or Dislocated; Noise, Audible

  PATIENT REVISED TO ADDRESS DISASSOCIATION, PAIN, IMPLANT FRACTURE, BURNING SENSATION, SQUEAKING, AND SOFT TISSUE INJURY.

  Patient problems: Burning Sensation; Discomfort; Inflammation; Injury; Limited Mobility Of The Implanted Joint; Loss of Range of Motion; Pain; Tissue Damage

  MAUDE report 7282808 ↗