PINNACLE POROCOAT 1217-01-062Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295008606), received between Dec 5, 2018 and Nov 10, 2025 — classified as 6 injuries, 1 malfunction.

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

• MalfunctionNov 10, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE IMPLANT WAS OPENED AND DEBRIS FROM THE CUP RUBBING ON THE PAPER ABOVE WAS OBSERVED.

  Patient problems: Insufficient Information

  MAUDE report 23512608 ↗
• InjuryOct 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE COMPONENTS WERE REMOVED DUE TO INFECTION AND REPLACED WITH ANTIBIOTIC SPACER. DOI: (B)(6) 2021; DOR: (B)(6) 2021; UNK HIP.

  Patient problems: Unspecified Infection

  MAUDE report 12656719 ↗
• InjuryAug 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NEW UNITY RECORD CREATED IN ORDER TO UPDATE ETQ COMPLAINT NUMBER (B)(4). LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL ION PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE, AND BONE. UPDATE REC'D 1/10/2014 ¿ PFS AND MEDICAL RECORDS RECEIVED. PART/LOT WAS PROVIDED. ORIGINAL LITIGATION MENTIONED ISSUES FROM METAL ON METAL; HOWEVER, THE STICKER SHEET INDICATES THAT THE PATIENT WAS ACTUALLY IMPLANTED WITH POLY AND CERAMIC. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: 2/4/2014 UPDATE AD 01 MAY 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS. THERE WERE NO NEW ALLEGATION AND REVISION REPORTED. ADDED STEM DUE TO PREVIOUSLY ALLEGED LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL ION. ADDED LAWYER IN THE ASSOCIATED CONTACT. UPDATE AD 16 JUL 2021. PFS AND MEDICAL RECORDS RECEIVED. PFS ALLEGES PAIN, SWELLING, SNAPPING, AND CLUNKING SOUND. PFS ALSO INDICATED THAT THE PATIENT IS USING CANE AND WHEELCHAIR. DOI: (B)(6) 2010 - DOR: NONE REPORTED (RIGHT HIP).

  Patient problems: Discomfort; Inflammation; Joint Laxity; Loss of Range of Motion; Pain

  MAUDE report 12306343 ↗
• InjuryDec 10, 2020Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  SURGEON REPORTED TO NCA (B)(6): "HIP-TEP LEFT SIDE ON (B)(6) 2013 IN OUR HOSPITAL. SINCE (B)(6)2020, AFTER A ROTATIONAL MOVEMENT WHILE WORKING IN THE GARDEN, PATIENT WAS EXPERIENCING INCREASING PAIN AND DISCOMFORT IN THE LEFT HIP JOINT. AFTER THIS, HE EXPERIENCED SQUEAKING NOISES IN THE LEFT JOINT PLUS FUNCTIONAL RESTRICTIONS AND PAIN UNDER LOAD. HIP-TEP RIGHT SIDE IN (B)(6) 2007; CONTENT WITH THIS ONE. THE X-RAY EXAMINATION INDICATED A DISLOCATED INLAY OF THE HIP-TEP ON THE LEFT. REVISION OF LEFT HIP-TEP ON (B)(6) 2020." ON (B)(6) 2020 THE PATIENT WAS REVISED FOR LEFT HIP TILTED, DISLOCATED CUP INSERT (DISASSOCIATION). THE LINER AND CUP WAS REVISED. CUP INSERT APPEARS TILTED AND ROTATED, NOW OPENING IN A LATERAL DIRECTION, RESULTING IN IMPINGEMENT OF THE HEAD AT THE LATERAL ACETABULAR MARGIN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Loss of Range of Motion; Pain

  MAUDE report 10983434 ↗
• InjuryAug 20, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  LITIGATION ALLEGES PATIENT WAS REVISED DUE TO PAIN AND ELEVATED IONS LEVELS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF CUP. ADDED DOB, AGE, LAW FIRM, ACCOUNT NAME, SURGEON, PRODUCT DETAILS AND IP. DOI: (B)(6) 2008, DOR: (B)(6) 2016, (LEFT HIP).

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8909992 ↗
• InjuryDec 11, 2018Biocompatibility; Biocompatibility

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM SEVERE PAIN AND DISCOMFORT IN HIS HIP, POSSIBLE INFECTION, SWELLING, METALLOSIS, AND DIFFICULTY WALKING. UPDATE AD 12 JUN 2018: WPC (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION IN WHAT WAS PREVIOUS ALLEGED. PPF ALLEGES INFECTION AND ELEVATED METAL IONS.

  Patient problems: Discomfort; Pain; Swelling; Test Result; Tissue Damage; Unspecified Infection

  MAUDE report 8151842 ↗
• InjuryDec 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8133164 ↗