PINNACLE POROCOAT 1217-22-064Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295009887), received between May 14, 2019 and Jul 15, 2022 — classified as 10 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2021. DATE OF REVISION: (B)(6) 2022. LEFT HIP TREATMENT: REMOVAL OF ALL COMPONENTS WERE DEPUY COMPONENTS REMOVED: YES.

  Patient problems: Unspecified Infection

  MAUDE report 15033841 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION AND DRAINAGE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. DATE OF IMPLANTATION:(B)(6) 2013. DATE OF REVISION #1: (B)(6) 2013. DATE OF REVISION #2: (B)(6) 2015. DATE OF REVISION #3: (B)(6) 2021. DATE OF REVISION #4: (B)(6) 2021. DATE OF EVENT: (B)(6) 2022. (LEFT HIP) TREATMENT: AWAITING REVISION.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 14700120 ↗
• InjuryJun 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  QUESTION: FOLLOW-UP FOR WHICH APEX HOLE ELIMINATOR (PRODUCT DETAILS): ''YOU HAVE PROVIDED US TWO DIFFERING APEX HOLE ELIMINATORS. AS IT IS NOT POSSIBLE FOR THE PATIENT TO HAVE HAD TWO OF THEM IMPLANTED, WHICH ONE WAS IN PLACE AT THE TIME OF THIS REVISION? ANSWER: THE ORIGINAL APEX HOLE ELIMINATOR WAS PROBABLY DAMAGED OR STRIPPED SO A NEW ONE WAS REQUIRED ON (B)(6) 2013.

  Patient problems: Hematoma; Impaired Healing

  MAUDE report 12062958 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE PATIENT HAD A REVISION OF LEFT TOTAL HIP ARTHROPLASTY TO ADDRESS WOUND BREAKDOWN WITH HEMATOMA AND DRAINAGE, RECURRENT INSTABILITY WITH DISLOCATION, AND COAGULOPATHY. THE INDICATIONS FOR SURGERY INCLUDED THAT THE PATIENT HAD A REVISION 6 WEEKS PRIOR (CAPTURED IN (B)(4)) TO ADDRESS A FAILED CONSTRAINED LINER AND MEDICAL RECORDS INDICATED THE PATIENT WAS HAVING PAIN.. THE PATIENT DISLOCATED AFTER THAT SURGERY AND NEEDED A REDUCTION. DURING THIS CURRENT PROCEDURE THE ACETABULAR AND FEMORAL COMPONENTS WERE REVISED. THE SURGEON REPORTED FINDING A COMPLETE FAILURE OF THE POSTERIOR SOFT TISSUE, AND REALLY NO LONGER ANY SOFT TISSUES PRESENT TO REPAIR. THERE WAS A SMALL AMOUNT OF HEMATOMA. HE WAS COAGULOPATHIC DURING THE CASE.

  Patient problems: Fluid Discharge; Hematoma; Joint Laxity; Pain; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 11871928 ↗
• InjuryJan 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS AND MEDICAL RECORDS RECEIVED. PFS ALLEGES PAIN, EMOTIONAL DISTRESS, ANXIETY AND NERVE PAIN AFTER FIRST REVISION. STEM WAS ALREADY REPORTED ON 1ST PC. DOI: (B)(6) 2018 (LINER & HEAD); DOI: (B)(6) 2008 (CUP); DOR: NONE REPORTED LEFT HIP.

  Patient problems: Anxiety; No Code Available; Pain

  MAUDE report 9623157 ↗
• InjuryDec 19, 2019Use of Device Problem; Migration; Use of Device Problem; Migration

  LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT AND TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE AND BONE. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED. PPF ALLEGES METAL WEAR, METALLOSIS, AND ELEVATED METAL IONS. DOI: (B)(6) 2010; DOR: (B)(6) 2014; (RIGHT HIP).

  Patient problems: Discomfort; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; No Code Available; Pain

  MAUDE report 9496885 ↗
• InjuryNov 1, 2019Loss of Osseointegration; Loss of Osseointegration

  PPF ALLEGES BONE FRACTURE BUT DID NOT INDICATE WHERE THE FRACTURE OCCURED. AT THIS TIME THE ACETABULAR CUP IS BEING REPORTED TO CAPTURE THE BONE FRACTURE AS IT'S THE MOST LIKELY TO FRACTURE.

  Patient problems: Bone Fracture(s); Discomfort; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 9269031 ↗
• InjuryOct 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT AND TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE AND BONE. UPDATE AD 05 SEP 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED. PPF ALLEGES INFECTION. DOI: (B)(6) 2005; DOR: (B)(6) 2008; (RIGHT HIP). THIS PC IS FOR THE FIRST REVISION OF THE RIGHT HIP. SEE (B)(4) FOR THE SECOND REVISION.

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

  MAUDE report 9185815 ↗
• InjuryJul 19, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS WEARING OF ACETABULAR LINER AS WELL AS BROKEN OF ANTI-ROTATIONAL PEGS ON THE LINER. DOI: (B)(6) 2006. DOR: (B)(6) 2019, UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available; Pain

  MAUDE report 8807914 ↗
• InjuryMay 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION: LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, DECREASED MOBILITY, AND POPPING NOISES. UPDATE: REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, LAB RESULTS FROM (B)(6) 2013 AND (B)(6) 2015 INDICATED METAL ION LEVELS WERE ABOVE 7PPB. UPDATE: THE MEDICAL RECORDS REPORTED DURING REVISION SURGERY THERE WAS A PSEUDOTUMOR, CORROSION AT THE JUNCTION OF THE HEAD AND NECK, AND TRUNNIONOSIS AT THE JUNCTION BETWEEN THE SHELL AND SOCKET AS WELL. THE PATHOLOGY REPORT NOTED INFLAMMATION AND FIBROSIS. UPDATE: PPF ALLEGES STROKE, HEART ATTACK, METAL WEAR AND METALLOSIS. DOI: (B)(6) 2007; DOR: (B)(6) 2015; (LEFT HIP).

  Patient problems: Cardiac Arrest; Discomfort; Fibrosis; Infarction, Cerebral; Inflammation; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Tissue Damage

  MAUDE report 8609434 ↗