BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE 100 ACET CUP 56MM

    MDR report key: 2991087 · Received March 6, 2013

    Report

    Report Number
    1818910-2013-13242
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    September 24, 2012
    Report Date
    February 7, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK000306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED DEVICES FINDS EVIDENCE TO SUPPORT DISASSOCIATION OF THE LINER AND CUP WHILE IMPLANTED. THERE IS EVIDENCE OF EDGE LOADING LEADING TO FAILURE OF THE POLYETHYLENE MATERIAL AND SUBSEQUENT DISASSOCIATION. DEVICE AND RECORDS EVALUATION DID NOT IDENTIFY OR VERIFY PRODUCT ERROR WITH REGARD TO THE REPORTED EVENT. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. THROUGH PRODUCT TRENDING, THE OCCURRENCE RATE FOR THIS TYPE OF FAILURE IS KNOWN TO BE VERY SMALL. BASED ON THE INVESTIGATION, PRODUCT CONTRIBUTION WAS NOT IDENTIFIED AND A NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS A WORN, FRACTURED POLY LINER. (B)(4) 2013 - PATIENT'S MEDICAL RECORDS WERE RECEIVED. REVISION NOTES INDICATE THE PATIENT HAD A DISASSOCIATION OF THE CUP AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95038 PINNACLE 100 ACET CUP 56MM CUP LPH DEPUY ORTHOPAEDICS, INC. ES2J31

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention