PINNACLE POROCOAT 1217-20-058Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295009658), received between Jul 11, 2017 and Dec 20, 2022 — classified as 7 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• InjuryDec 20, 2022Use of Device Problem; Device Dislodged or Dislocated; Use of Device Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PINNACLE LINER DISENGAGED FROM THE SHELL. DOCTOR SEEMS TO THINK IT WAS DUE TO THE CUP POSITION. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 16014084 ↗
• InjurySep 2, 2020Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS ORIGINALLY AN ASR PATIENT IMPLANTED (B)(6) 2007 AND REVISED ON (B)(6) 2009 TO PINNACLE PRODUCTS AND HAS SINCE BEEN REVISED TO FURTHER PINNACLE PRODUCTS AND THESE HAVE ALSO BEEN REVISED. ASR SURGERY: ASR XL IMPLANTED (B)(6) 2007. ASR REVISED (B)(6) 2009 ¿ STEM REMAINED IN SITU. 1ST PINNACLE SURGERY: PINNACLE CUP, HEAD, LINER IMPLANTED (B)(6) 2009. ACETABULAR CUP PINNACLE MULTIHOLE 58 REF: 1217-20-058. CERAMIC FEMORAL HEAD REF: 1365-35-740. METAL INSERT PINNACLE REF: 121887358. PINNACLE CUP, HEAD, LINER REVISED (B)(6) 2010 - STEM REMAINED IN SITU. REASON FOR REVISION ¿ PAIN, DISLOCATION OF IMPLANT. UPDATE AD 18 AUG 2020: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO CLAIMSUITE ALERTS RECEIVED. CLAIMSUITE ALERT ALLEGES ACETABULAR & FEMORAL COMPONENT LOOSENING. ADDED ASSOCIATED CONTACT, PATIENT HARM AND CONCOMITANT PRODUCTS. DOI: (B)(6) 2009 - DOR: (B)(6) 2010 (LEFT HIP). (B)(4) 1ST REVISION.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 10483920 ↗
• InjuryMar 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT COMPLAINS OF DRAINAGE FROM THE WOUND. INSPECTION REVEALED DEHISCENCE OF SURGICAL INCISION. THE PATIENT WAS THEN REVISED FOR RIGHT TOTAL HIP INFECTION. OPERATIVE NOTES REPORTED SOME PURULENT MATERIAL WERE ENCOUNTERED. INSPECTION OF THE JOINT REVEALED THAT THE CAPSULE WAS DEFICIENT. IT WAS ALSO INDICATED THAT 200 ML BLOOD LOSS AND 1 UNIT TRANSFUSION OF PRBC. DOI: (B)(6) 2008 (STEM); DOI: (B)(6) 2008 (CUP, HEAD, LINER); DOR: (B)(6) 2008; RIGHT HIP.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Code Available; Tissue Damage; Unspecified Infection; Wound Dehiscence

  MAUDE report 9811739 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION RECORD RECEIVED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, DISCOMFORT AND INFECTION. THE PATIENT HAD A PREVIOUS REVISION WHERE ONLY CUP AND LINER REMAINED TO BE A DEPUY PRODUCT. DOI: (B)(6) 2014; DOR: (B)(6) 2018.

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

  MAUDE report 9505559 ↗
• InjuryOct 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION: (B)(6) 2017: LITIGATION RECEIVED. LITIGATION ALLEGES CORROSION AND FRICTION WEAR CAUSED AMOUNTS OF TOXIC COBALT-CHROMIUM METAL DEBRIS, THUS, PATIENT EXPERIENCING PAIN, DISCOMFORT AND INFLAMMATION. PATIENT ALSO EXPERIENCED EXTREME DISCOMFORT WHEN SITTING FOR PERIODS OF TIME, WALKING, STANDING OR SITTING. UPDATE AD 17 MAY 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO RECEIPT OF LITIGATION RECORDS. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED. LITIGATION ALLEGES EXCISION OF A LARGE PSEUDOTUMOR, INJURIES, EMOTIONAL DISTRESS, DISABILITY AND DISFIGUREMENT. DOI: (B)(6) 2006; DOR: (B)(6) 2016; LEFT HIP.

  Patient problems: Discomfort; Edema; Hypersensitivity/Allergic reaction; Injury; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Pulmonary Embolism; Unspecified Infection

  MAUDE report 9139432 ↗
• InjuryDec 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION: LITIGATION ALLEGES THE PATIENT SUFFERS FROM TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE AND BONE, PAIN, DISCOMFORT, INFLAMMATION AND A POPPING AND SNAPPING SENSATION IN HIS HIP JOINTS. LITIGATION ALLEGED HIGH METAL IONS, BUT AFTER REVIEW OF THE MEDICAL RECORDS IT SHOWED THE PATIENT HAD A POLY LINER AND A CERAMIC HEAD IMPLANTED. PPF ALLEGED INFECTION. DOI: (B)(6) 2006 - DOR: (B)(6) 2007 (LEFT HIP).

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

  MAUDE report 8166207 ↗
• InjuryJul 11, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6700461 ↗