PINNACLE POROCOAT 1217-20-054Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295009634), received between Feb 28, 2018 and Jul 20, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 20, 2023Osseointegration Problem; Migration; Osseointegration Problem; Migration

  THE PATIENT WAS REVISED DUE TO NON-CEMENTED LOOSENING OF THE ACETABULUM. THE CUP HAD SPUN OUT AND BECOME LOOSE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17363552 ↗
• InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED THROUGH CD SHIPMENT. AFTER REVIEW OF MEDICAL RECORDS, THERE A MULTIPLE DEBRIDEMENT AND INFECTION, CELLULITIS, PAIN, WOUND PURULENCE WITH DYSURIA, FRACTURE OF THE PROXIMAL FEMORAL SHAFT AND DEPRESSION AND ANXIETY. DOI: (B)(6) 2008: DOR: UNKNOWN; RIGHT HIP (SECONDARY).

  Patient problems: Anxiety; Cellulitis; No Code Available; Pain; Tissue Damage; Unspecified Infection

  MAUDE report 8949313 ↗
• InjuryJan 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES PULMONARY EMBOLISM AFTER FIRST REVISION.

  Patient problems: Pulmonary Embolism

  MAUDE report 8273692 ↗
• InjuryJan 3, 2019Loss of Osseointegration; Loss of Osseointegration

  LITIGATION ALLEGES THE PATIENT SUFFERS FROM ELEVATED LEVELS OF CHROMIUM AND COBALT, PAIN AND TISSUE INFLAMMATION. PPF ALLEGES LOOSENING OF CUP AND LOOSENING OF STEM. DOI: (B)(6) 2010 - DOR: (B)(6) 2013 (LEFT HIP).

  Patient problems: Inadequate Osseointegration; Inflammation; No Code Available; Pain

  MAUDE report 8212076 ↗
• InjuryDec 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THAT IMPLANT RELEASED METAL IONS INTO PATIENT'S BLOOD, TISSUE, AND BONE SURROUNDING THE IMPLANT. AS A RESULT, PATIENT HAS EXPERIENCED SEVERE PAIN, DISCOMFORT, AND INFLAMMATION IN THIGH AND GROIN. PATIENT HAS ALSO EXPERIENCED AN INABILITY TO WALK, FROZEN JOINT AND CAN ONLY STAND FOR THREE MINUTES. UPDATE: IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGED INFECTION. DOI: (B)(6) 2010 - DOR: (B)(6) 2013 (RIGHT HIP).

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

  MAUDE report 8137420 ↗
• InjuryAug 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PPF ALLEGES INFECTION REQUIRING INTRAVENOUS ANTIBIOTICS AFTER FIRST REVISION. DOI: (B)(6) 2008 -DOR: NONE REPORTED (RIGHT HIP).

  Patient problems: Unspecified Infection

  MAUDE report 7788475 ↗
• InjuryFeb 28, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2017; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Pain

  MAUDE report 7302643 ↗