PINNACLE POROCOAT 1217-03-056Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295008675), received between Aug 3, 2017 and Apr 30, 2026 — classified as 21 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD A HISTORY OF A METAL-METAL ARTICULATING TOTAL HIP ARTHROPLASTY OF THE RIGHT HIP. ON (B)(6) 2024, AN MRI OF THE RIGHT HIP REVEALED THE PRESENCE OF FLUID COLLECTION EMANATING FROM THE JOINT. LABORATORY EVALUATION DEMONSTRATED ELEVATED PLASMA METAL ION LEVELS. ON (B)(6) 2026, THE PATIENT UNDERWENT REVISION SURGERY OF THE RIGHT TOTAL HIP ARTHROPLASTY DUE TO MECHANICAL FAILURE SECONDARY TO METAL HYPERSENSITIVITY, RESULTING IN AN ADVERSE LOCAL TISSUE REACTION (ALTR). DOI: (B)(6) 2009 DOR: (B)(6) 2026 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Hypersensitivity/Allergic reaction; Metal Related Pathology; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 25046358 ↗
• InjuryOct 14, 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 WAS REVISED DUE TO RECURRENT DISLOCATION, FAILED OSTEOTOMIES AND INFECTION. CLINICAL VISIT REPORTED DISLOCATION, SEROUS DRAINAGE FROM SURGICAL SCAR DUE TO AN INFECTED LEFT REVISION HIP. DOI: (B)(6) 2020, DOR: (B)(6) 2020 LEFT HIP SECOND REVISION.

  Patient problems: Adhesion(s); Joint Dislocation; Scar Tissue; Unspecified Infection

  MAUDE report 12631296 ↗
• InjuryAug 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS FROM (B)(6) 2021 NOTE THAT THE PATIENT HAS SEVERE LEFT HIP PAIN AFTER A STUMBLE AND FALL. THE IMPLANTS CONSISTED OF A CORAIL UNCEMENTED FEMORAL STEM, AND A PINNACLE CUP WITH A METAL ON METAL BEARING SURFACE. DOI: (B)(6) 2010, DOR: (B)(6) 2021. LEFT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fall; Osteolysis; Pain

  MAUDE report 12325345 ↗
• InjuryAug 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE PFS AND MEDICAL RECORDS RECEIVED. PFS ALLEGES PAIN, SLEEPING DISTURBANCE, DISCOMFORT RIGHT LEG, HIP, WALKING DIFFICULTY AND INSTABILITY. MISS OUT WORK DUE TO HIP PAIN, SURGERY AND RECOVERY. PLAINTIFF IS SEEKING COMPENSATION FOR ALL THE INJURIES AND FINANCIAL LOSSES. AFTER REVIEW OF THE MEDICAL RECORDS THE LAB RESULT MRI HIP REPORTED THERE WAS A STREAK ARTIFACT DESPITE METAL ARTIFACT REDUCTION. THERE IS A MILD ATROPHY OF THE RIGHT ILIOPSOAS AND HAMSTRING TENDINOPATHY. MILD DEGENERATIVE ARTHROSIS OF THE SYMPHYSIS PUBIS AND PUBALGIA. COBALT AND CHROMIUM RESULT WERE BELOW 7 PPB. DOI: (B)(6) 2010; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Fall; Joint Laxity; Pain; Physical Asymmetry; Unspecified Tissue Injury

  MAUDE report 12309023 ↗
• InjuryAug 26, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT REVISED TO ADDRESS NOISE AFTER A FALL. FOUND LINER IMPACTED AT ANGLE. UPDATE: 6/10/13 - LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, AND DIFFICULTY AMBULATING. A FEMORAL HEAD IS NOW BEING REPORTED TO ADDRESS THESE ISSUES. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESS FAILED LEFT TOTAL HIP ARTHROPLASTY SECONDARY TO FEMORAL NECK, LINER IMPINGEMENT, LINER MALPOSITION. REVISION NOTES REPORTED OF SCAR TISSUES WAS REMOVED IN ACETABULUM AND THE DISASSOCIATED THE METAL ON METAL ARTICULATION. ADDED UNKNOWN CUP DUE TO DISASSOCIATION. DOI: (B)(6) 2004 - DOR: (B)(6) 2008, (LEFT HIP).

  Patient problems: Discomfort; Inflammation; Loss of Range of Motion; No Code Available; Pain; Scar Tissue

  MAUDE report 8930107 ↗
• InjuryApr 18, 2019Loss of Osseointegration; Loss of Osseointegration

  PPF ALLEGES CUP LOOSENING. DOI: (B)(6) 2005 (CUP); DOR: (B)(4) 2009 (RIGHT HIP).

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8528747 ↗
• InjuryApr 18, 2019Use of Device Problem; Use of Device Problem

  AFTER REVIEW OF CLAIM AND MEDICAL RECORDS, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS METALLOSIS. THE OPERATIVE REPORT INDICATED SOME GRAY FLUID AND A TREMENDOUS AMOUNT OF SCAR TISSUE WITH SOME GRAY SYNOVITIS WHICH WAS THEN DEBRIDED. METAL DEBRIS WERE CLEANSED VIA PULSED LAVAGE IRRIGATION. ADDITIONALLY THE PATIENT WAS EXPERIENCING PAIN AND HAD EXCESSIVE METAL IONS IN HIS SERUM. THE ACETABULAR COMPONENT WAS NOTED TO BE VERY VERTICAL THUS A FISHING LINER TO CHANGE THE CENTER ROTATION WAS TRIALED. NO LAB RESULTS PROVIDED. (LEFT HIP).

  Patient problems: No Code Available; Pain; Scar Tissue; Tissue Damage

  MAUDE report 8528351 ↗
• InjuryApr 16, 2019Osseointegration Problem; Osseointegration Problem

  PPF ALLEGE LOOSENING OF CUP. DOI: (B)(6) 2005; DOR: (B)(6) 2006 (LEFT HIP).

  Patient problems: Inadequate Osseointegration

  MAUDE report 8517793 ↗
• InjuryMar 5, 2019Loss of Osseointegration; Loss of Osseointegration

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES LOOSENING OF CUP, FRACTURE (COMPONENT), METAL WEAR AND METALLOSIS. DOI: (B)(6) 2008 - DOR: (B)(6) 2009 (RIGHT HIP). PATIENT IS BILATERAL.

  Patient problems: Inadequate Osseointegration; No Code Available; Tissue Damage

  MAUDE report 8390624 ↗
• InjuryFeb 20, 2019Use of Device Problem; Use of Device Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. X-RAY INDICATED A VERTICAL ACETABULAR CUP. THE CUP WAS FOUND TO BE LOOSE AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2008; DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8353993 ↗
• InjuryFeb 1, 2019Loss of Osseointegration; Loss of Osseointegration

  PFS AND MEDICAL RECORDS RECEIVED. PFS ALLEGES PAIN. NO DATE OF REVISION HAS BEEN PROVIDED AT THIS TIME. UPDATE PPF ALLEGES LOOSENING OF CUP AND METAL WEAR/METALLOSIS. DOI: (B)(6) 2010 - DOR: NOT REPORTED, (LEFT HIP).

  Patient problems: Inadequate Osseointegration; Pain; Tissue Damage

  MAUDE report 8296918 ↗
• InjuryJan 31, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  LITIGATION ALLEGES INFECTION AND CUP LOOSENING. DOI: (B)(6) 2005; DOR: (B)(6) 2014; (LEFT HIP).

  Patient problems: Hypersensitivity/Allergic reaction; Inadequate Osseointegration; No Code Available; Tissue Damage; Unspecified Infection

  MAUDE report 8292786 ↗
• InjuryJan 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALTHOUGH THERE ARE NO PATIENT SPECIFIC ALLEGATIONS, GENERAL LITIGATION ALLEGES METAL ON METAL, UPDATE 6/19/15- PFS RECEIVED. PFS NOW ALLEGES PAIN, METALLOSIS AND HIGH METAL IONS. UPDATE AD 04 MAY 2018: RECEIPT OF PPF AND STICKER SHEETS. PPF ALLEGES LOOSENING OF CUP, METAL WEAR AND METALLOSIS.

  Patient problems: No Code Available; Pain; Tissue Damage

  MAUDE report 8260565 ↗
• InjuryNov 20, 2018Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  LITIGATION PAPERS ALLEGE SHORTLY AFTER SURGERY, PATIENT BEGAN EXPERIENCING PAIN AND TENDERNESS IN HIS LEFT HIP AND GROIN. IT IS ALSO ALLEGED THE PAIN AND TENDERNESS HAS NEVER GONE AWAY AND OFTEN IS SO UNBEARABLE THAT PATIENT CANNOT STAND OR WALK. UPDATE PPF ALLEGES LOOSENING OF CUP, LOOSENING OF STEM, METAL WEAR, METALLOSIS, AND ELEVATED METAL IONS. PPF ALSO ALLEGES PULMONARY EMBOLISM AFTER THE FIRST REVISION, HOWEVER, IT IS NOT SUGGESTED THAT DEPUY PRODUCTS WERE CONTRIBUTORY OR INVOLVED. DOI: (B)(6) 2007 - DOR: (B)(6) 2012; (LEFT HIP).

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

  MAUDE report 8089288 ↗
• InjuryNov 1, 2018Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  PPF AND STICKER SHEETS RECORD RECEIVED. PPF ALLEGES BONE FRACTURE, DISLOCATION WITH CLOSED REDUCTION, AND INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8030237 ↗
• InjurySep 25, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  LITIGATION ALLEGES LOOSENING. DOI: (B)(6) 2004, DOR: (B)(6) 2012 (RIGHT HIP).

  Patient problems: Inadequate Osseointegration; Not Applicable; Pain

  MAUDE report 7905827 ↗
• InjuryJul 20, 2018Loss of Osseointegration; Loss of Osseointegration

  NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT.- PATIENT REVISED FOR PAIN. UPDATE 10/2/2012- LITIGATION PAPERS RECEIVED. IN ADDITION TO PAIN, IT IS ALSO ALLEGED THAT THE PATIENT SUFFERS FROM DISCOMFORT AND INFLAMMATION, AS WELL AS, LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE, AND BONE SURROUNDING THE IMPLANT. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. UPDATE: 11/29/2012 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. UPDATE AD 26 MAY 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND MEDICAL RECORD. PPF ALLEGES LOOSENING OF CUP, ABDUCTOR MUSCLE REPAIR,LOOSENING OF STEM, AFTER REVIEW OF MEDICAL RECORD OF MDR REPORTABILITY, DOI - (B)(6) 2007 / DOR (B)(6) 2010 (LEFT HIP).

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

  MAUDE report 7705831 ↗
• InjuryJun 28, 2018Osseointegration Problem; Insufficient Device Problem Information; Osseointegration Problem; Insufficient Device Problem Information

  NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT.- PATIENT WAS REVISED TO ADDRESS PAIN. DOI 2009; DOR (B)(6) 2012; (LEFT HIP). UPDATE 7/16/12 - LITIGATION PAPERS WERE RECEIVED. THERE IS NO NEW INFORMATION THAT WOULD AFFECT THE INVESTIGATION. UPDATE: 10/31/2012 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL. RECORDS INDICATE THAT THE PATIENT WAS REVISED BECAUSE OF PAIN AND METALLOSIS. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. UPDATE REC'D 2/12/2014- PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE REVISION OPERATIVE NOTE THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: 03/10/14. ADDITIONAL INFORMATION: DOI: (B)(6) 2009; DOR: (B)(6) 2012; (LEFT HIP). 12/9/14 UPDATE PATIENT HARMS AND/OR COMPLAINT CATEGORY NR. UPDATE AD 29 MAY 2018: (B)(4) HAS BEEN REOPENED UNDER (B)(4) DUE TO RECEIPT OF PFF AND STICKER SHEETS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PFF ALLEGES INFECTION REQUIRING ANTIBIOTICS, METAL WEAR AND METALLOSIS CONFIRMED IN THE MEDICAL RECORD

  Patient problems: Inadequate Osseointegration; Pain; Tissue Damage; Unspecified Infection

  MAUDE report 7645738 ↗
• InjuryMar 5, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED TO ADDRESS ELEVATED COCR LEVELS AND LOOSENING OF THE CUP COMPONENT AT BONE TO IMPLANT INTERFACE. DOI: UNKNOWN. DOR: (B)(6) 2018. UNKNOWN HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 7312735 ↗
• InjurySep 15, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE PATIENT UNDERGONE HIP REPLACEMENT IN 2005 PER THE SURGEON, UNEVENTFUL UNTIL THE LAST 6 MONTHS. THEN THE PATIENT HAD A PERIODS OF PAIN. SURGEON STATED HE FELT HE NEEDED TO CONVERT THE METAL/METAL CONSTRUCT TO A CERAMIC HEAD ON POLY LINER.

  Patient problems: Pain

  MAUDE report 6868749 ↗
• MalfunctionAug 30, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  LINER WASN'T ABLE TO BE REMOVED FROM THE CUP, THEY WERE REMOVED TOGETHER DURING THE REVISION SURGERY.

  Patient problems: No Information

  MAUDE report 6831856 ↗
• InjuryAug 3, 2017Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  COMPLAINT DESCRIPTION: LITIGATION ALLEGES PATIENT SUFFERS FROM PAIN AND TENDERNESS. UPDATE 9/8/2015-PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE PART/LOT IS BEING UPDATED. NO REVISION OPERATIVE NOTE WAS INCLUDED. THE COMPLAINT WAS UPDATED ON:10/6/2015 UPDATE JUL 5, 2017: LEGAL MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PFS ALLEGES BALL COMING OUT OF SOCKET AND POOR SENSE OF BALANCE. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY. REVISION NOTE STATED METALLOSIS CONSISTENT THE METAL-ON-METAL COMPONENTS, SOME METALLOSIS IN THE DEBRIS AT THE PROXIMAL END OF THE FEMUR WAS SOLIDLY FIXED, BONE LOSS SUPERIORLY. EVALUATION NOTE REPORTED RADIOGRAPH SHOWED ANTERIOR SUBLUXATION OF THE HEAD AND THE CUP LOOKS VERTICAL. ADDED CUP DUE TO THE REPORTED VERTICAL CUP POSITION. THIS COMPLAINT WAS UPDATED ON: JUL 24, 2017. / / INVESTIGATION METHOD: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW, WAS NOT POSSIBLE BECAUSE THE REQUIR

  Patient problems: No Information; Pain; Tissue Damage

  MAUDE report 6763151 ↗