PINNACLE POROCOAT 1217-20-062Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295009672), received between Sep 24, 2018 and Dec 16, 2021 — classified as 3 injuries.

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

• InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION RECORDS RECEIVED. AFTER REVIEW OF RECORDS, LEGITIMATION ALLEGES THAT PATIENT CONTINUES TO SUFFER ECONOMIC, DAMAGES, SEVERE AND POSSIBLY PERMANENT INJURIES, PAIN, SUFFERING AND EMOTIONAL DISTRESS. DOI: (B)(6) 2007 (CUP AND STEM); DOI: (B)(6) 2019 (HEAD AND LINER); DOR: NONE REPORTED; RIGHT HIP. THIS COMPLAINT IS LINKED TO: (B)(4) - RIGHT HIP 1ST REVISION; (B)(4) - LEFT HIP 1ST REVISION; (B)(4) - ALLEGATION AFTER 1ST REVISION OF LEFT HIP.

  Patient problems: Distress; Pain

  MAUDE report 13018391 ↗
• InjuryAug 14, 2019Loss of Osseointegration; Loss of Osseointegration

  PPF AND STICKER SHEETS RECORD. PPF ALLEGES LOOSENING OF CUP, LOOSENING OF STEM AND ELEVATED METAL IONS AFTER 1ST REVISION. LINER WAS POLY AND STEM WAS ALREADY REPORTED IN (B)(4). DOI: (B)(6) 2011 - DOR: NONE REPORTED, (LEFT HIP).

  Patient problems: Inadequate Osseointegration

  MAUDE report 8892888 ↗
• InjurySep 24, 2018Osseointegration Problem; Osseointegration Problem

  PPF AND MEDICAL RECORDS RECEIVED. PPF ALLEGES DISLOCATION WITH OPEN AND CLOSED REDUCTION AND LOOSENING OF THE CUP AFTER THE FIRST REVISION. AFTER REVIEW OF MEDICAL RECORDS FOR THE MDR REPORTABILITY, THE OPERATIVE NOTES DURING THE SECOND AND THIRD REVISION DOES NOT SUPPORT THE PPF ALLEGATION AFTER THE FIRST REVISION. HEAD, LINER, AND CUP WERE REPORTED TO THE IMPACTED PRODUCT DUE TO DISLOCATION AND LOOSENING OF THE CUP. DOI: (B)(6) 2009; DOR: NONE REPORTED; (LEFT HIP). (B)(4) (LEFT HIP) FIRST REVISION; (B)(4) (LEFT HIP) SECOND REVISION; (B)(4) (LEFT HIP) THIRD REVISION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7901447 ↗