PINNACLE POROCOAT 1217-03-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295008699), received between Sep 11, 2018 and Aug 9, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD DISLOCATION. NEEDED TO REVISE MOM LINER TO CONSTRAINED POLY. NO SIGNS OF METALLOSIS. THE SURGEON DID NOT BELIEVE MOM WAS THE CONCERN IN THIS CASE. DOI: UNKNOWN. DOR: (B)(6) 2021. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Loss of Range of Motion; Necrosis; Osteolysis; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 17486595 ↗
• InjuryApr 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS MECHANICAL COMPLICATION RIGHT HIP PROSTHESIS AND METALLOSIS RIGHT HIP JOINT. PATIENT ALLEGES ELEVATED METAL IONS, PAIN, SWELLING OF RIGHT THIGH, METALLOSIS, DYSFUNCTION, AND DISCOMFORT. OPERATIVE NOTES STATED THAT THERE WAS SEVERE METALLOSIS AROUND THE TRUNNION. CASEATRING NECROTIC TISSUE WAS DEBRIDED FROM AROUND THE PROXIMAL FEMUR. ATTENTION WAS TURNED TO THE ACETABU!AR COMPONENT. PERIPHERAL NECROTIC TISSUE WAS DEBRIDED. THERE WAS EVIDENCE OF METALLOSIS BETWEEN THE JUNCTION OF THE METAL LINER AND THE SHELL. LABORATORY RESULT SHOWS OF ELEVATED METAL IONS. DOI: (B)(6) 2005; DOR: (B)(6) 2019 (RIGHT HIP).

  Patient problems: Discomfort; Edema; Foreign Body Reaction; Limited Mobility Of The Implanted Joint; Necrosis; No Code Available; Pain

  MAUDE report 9929412 ↗
• InjurySep 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS AND MEDICAL RECORDS RECEIVED. THE PATIENT WAS REVISED FOR INFECTION ON (B)(6) 2016. ALL IMPLANTS WERE REMOVED. THE STEM AND FEMORAL HEAD ARE COMPETITOR PRODUCTS. THERE WAS A 1800ML BLOOD LOSS NOTED DURING THE (B)(6) 2016 REVISION, WITH NO INDICATION OF THE CAUSE. AT THIS TIME THERE IS NO INFECTION ALLEGED PER THE LITIGATION. **IT SHOULD BE NOTED THAT THE STEM AND HEAD WERE REVISED ON 1/12/2016 FOR A FRACTURED STEM ((B)(4)). UPDATE AD 8 AUG 2018: PPF AND IMPLANT RECORDS AND STICKER SHEET RECORDS RECEIVED. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES ABDUCTOR MUSCLE REPAIR. DOI: (B)(6) 2009(CUP), (B)(6) 2013(LINER) - DOR: (B)(6) 2016 (RIGHT HIP)

  Patient problems: No Code Available; Not Applicable; Tissue Damage; Unspecified Infection

  MAUDE report 9136011 ↗
• InjuryMar 25, 2019Loss of Osseointegration; Loss of Osseointegration

  LITIGATION ALLEGES THE PATIENT SUFFERS FROM DISLOCATION AND INFECTION. UPDATE AD 05 SEP 2018: RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF CUP.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 8447726 ↗
• InjuryDec 14, 2018Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available; Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION AND LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8164017 ↗
• InjurySep 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES HEART ATTACK/STROKE. DOI: (B)(6) 2015 - DOR: NONE REPORTED, (RIGHT HIP).

  Patient problems: Cardiac Arrest; Infarction, Cerebral

  MAUDE report 7863677 ↗