PINNACLE POROCOAT 1217-22-066Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295009894), received between Oct 6, 2020 and Jul 9, 2024 — classified as 3 injuries.

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

• InjuryJul 9, 2024Osseointegration Problem; Osseointegration Problem

  PATIENT WAS RETURNED TO SURGERY AFTER HIS ACETABULAR CUP CAME LOOSE. DURING THE REVISION THE STEM WAS NOT LOOSE BUT WAS REMOVED TO ALLOW ACCESS TO THE ACETABULUM FOR THE REVISION, A NEW GRIPTION MULTI-WHOLE CUP WAS PLACED MORE MEDIAL AND LOWER. THE STEM AND HEAD WERE REPLACED. THERE WERE NO SURGICAL DELAYS OR BROKEN INSTRUMENTS WAS REPORTED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19700482 ↗
• InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO AN UNSTABLE HIP. NO SURGICAL DELAY NOTED. DOI: NOT INDICATED/UNKNOWN, DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 10960090 ↗
• InjuryOct 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED PAIN, ELEVATED METAL ION LEVELS. OPERATIVE NOTES INDICATED EVIDENCE OF TRUNNIONOSIS WITH BLACK METAL DEBRIS AT THE TRUNNION. DURING OPERATION ANESTHESIA INFORMED THAT THE PATIENT WAS NOT DOING WELL IN FACT WENT INTO SEVERE BRADYCARDIA AND HYPOXIA AND AN EMERGENT CODE WAS CALLED AT WHICH POINT THEY SEALED THE WOUND WITH IOBAN EMERGENTLY FLIPPED THE PATIENT ONTO HIS BACK AND BEGAN CHEST COMPRESSION. THE PATIENT WAS SUCCESSFULLY RESUSCITATED AND WAS STABLE AFTER MULTIPLE MEDICATIONS GIVEN. DOI: (B)(6) 2008; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Atrial Tachycardia; Foreign Body Reaction; No Code Available; Pain; Test Result

  MAUDE report 10638179 ↗