PINNACLE POROCOAT 1217-03-048Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295008637), received between Aug 25, 2017 and May 14, 2020 — classified as 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL HIP. DOI: UNKNOWN. DOR: (B)(6) 2020; RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10057139 ↗
• InjuryDec 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ACETABULUM WAS FRACTURED WHILE INSERTING ACETABULAR SHELL. THE PATIENT WAS CONVERTED TO A HEMIARTHROPLASTY AND THE PROCEDURE WAS COMPLETED. LEFT HIP.

  Patient problems: Bone Fracture(s)

  MAUDE report 9417248 ↗
• InjuryAug 12, 2019Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT HAD A REVISED CUP AND POLY DUE TO WEAR AND PAIN. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 8885537 ↗
• InjuryApr 24, 2019Use of Device Problem; Use of Device Problem

  CLAIM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF CLAIM AND MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS RECALCITRANT INSTABILITY. OPERATIVE NOTES REPORTED THAT PATIENT WAS UNSTABLE IN FLEXION AND THERE WAS ABDUCTION OF THE CUP. DOI: (B)(6) 2007; DOR: (B)(6) 2007; LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 8544078 ↗
• InjuryApr 18, 2019Use of Device Problem; Use of Device Problem

  AFTER REVIEW MEDICAL RECORDS, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS PAIN, ANTERIOR INSTABILITY AND METALLOSIS. OPERATIVE FINDINGS REPORTED METALLOSIS, BACKSIDE WEAR OF THE METAL LINER IN THE ACETABULAR SHELL AND SIGNIFICANT RETROVERSION OF ACETABULAR SHELL. LEFT HIP.

  Patient problems: No Code Available; Pain; Tissue Damage

  MAUDE report 8527425 ↗
• InjuryAug 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PINNACLE PPF AND MEDICAL RECORDS RECEIVED. PPF ALLEGES COMPONENT FRACTURE, DISLOCATION WITH CLOSED REDUCTION AND INFECTION. THERE IS NO REVISION REPORTED AT THIS TIME. DOI: (B)(6) 2011; DOR: NOT REPORTED; RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 7738677 ↗
• InjuryJun 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES DISLOCATION AND INFECTION. DOI: (B)(6) 2015 - DOR: NOT REPORTED (LEFT HIP).

  Patient problems: Unspecified Infection

  MAUDE report 7620121 ↗
• InjuryAug 25, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES REVISION OF HEAD, LINER AND POSSIBLY CUP WAS SCHEDULED DUE TO PATIENT EXPERIENCING PAIN.

  Patient problems: Pain

  MAUDE report 6819993 ↗