PINNACLE POROCOAT 1217-03-064Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295008712), received between Dec 3, 2018 and Jun 27, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE IMPLANTS WERE IMPLANTED IN THE RIGHT HIP ON (B)(6) 2007. REVISED ON (B)(6) 2011, FEMORAL OSTEOLYSIS, INFECTION. COBALT AND CHROMIUM ARE 14 AND 9, PAIN. ALL IMPLANTS WERE REMOVED. OSTEOTOMY WAS USED TO REMOVE THE AML STEM. PROSTALAC WAS IMPLANTED. LOOSE CUP WAS NOTED PRE-OP, BUT OPERATIVE NOTED INDICATED IT WAS EMBEDDED AND THERE WAS NO INDICATION OF LOOSENING. PICC LINE WAS PLACED FOR TREATMENT OF INFECTION. SECOND STAGE REVISION ON (B)(6) 2012 ¿ COMPETITOR STEM PLACED WITH PINNACLE CUP. DOI: (B)(6) 2007. DOR: (B)(6) 2011. RIGHT HIP.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 19624335 ↗
• InjuryFeb 17, 2021Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS WERE RECEIVED AND STATED THE FOLLOWING: ON (B)(6)2019, A PROGRESS REPORTED THAT PATIENT PRESENTED WITH WORSENING PAIN AND DEVELOPED FEVER. PATIENT WAS DIAGNOSED INFECTION AND INFLAMMATORY RESPONSE OF THE INTERNAL RIGHT HIP PROSTHESIS.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Extraskeletal ossification; Fever; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Joint Laxity; Loss of Range of Motion; Necrosis; Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Thrombosis/Thrombus; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11338675 ↗
• InjuryMar 25, 2019Use of Device Problem; Use of Device Problem

  PPF ALLEGES PSEUDOTUMOR AND METAL WEAR.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Swelling; Tissue Damage

  MAUDE report 8447908 ↗
• InjuryJan 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGED PAIN, DISCOMFORT, INFECTION, AMBULATORY IMPAIRMENT, AND HIGH LEVELS OF COBALT AND CHROMIUM.

  Patient problems: Discomfort; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Unspecified Infection

  MAUDE report 8228028 ↗
• InjuryDec 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. UPDATE PPF ALLEGES INFECTION AFTER 1ST REVISION. DOI: (B)(6) 2011 - DOR: (B)(6) 2011 (RIGHT HIP).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8125395 ↗