PINNACLE POROCOAT 1217-03-062Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295008705), received between Nov 7, 2018 and Jan 14, 2020 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

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

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL STEM COMPONENT AT BONE TO IMPLANT INTERFACE. LOOSENING IS DUE TO METALLOSIS FROM METAL ACETABULUM LINER. UPDATE 27 MAR 2019: (B)(4) HAS BEEN RE-OPENED DUE TO RECEIPT OF UNF AND MEDICAL RECORDS. UNF HAS NO NEW ALLEGATION. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESSED MECHANICAL FAILURE OF LEFT HIP REPLACEMENT WITH ASEPTIC LOOSENING. CHRONIC HEMARTHROSIS AND ORGANIZED CLOT WAS NOTED WITHIN THE HIP JOINT. NOTED OF MOVEMENT AT BONE CEMENT INTERFACE OF THE FEMORAL COMPONENT SIGNIFYING GROSS LOOSENING. ORGANIZED HEMATOMA WAS EVACUATED FROM THE ACETABULUM. ADDED DATE OF BIRTH, MEDICAL HISTORY, LAW FIRM, LAWYER, SURGEON, PRODUCT DETAILS OF LINER, HEAD AND STEM (LOT NUMBER, MANUFACTURING DATE AND GTIN) IN IMPACTED PRODUCTS. CORRECTED DATE OF IMPLANT. DOI: (B)(6) 2006. DOR: (B)(6) 2017, LEFT HIP.

  Patient problems: Foreign Body Reaction; Hematoma; No Code Available

  MAUDE report 9586564 ↗
• InjuryNov 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PULMONARY EMBOLISM AFTER FIRST REVISION.

  Patient problems: Pulmonary Embolism

  MAUDE report 8047739 ↗