BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS FEMORAL STEM BEADED FULLCOAT

    MDR report key: 2063741 · Received April 14, 2011

    Report

    Report Number
    1822565-2011-00954
    Event Type
    Injury
    Date Received
    April 14, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 18, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: SURGICAL NOTES DID NOT REVEAL ANY COMPLICATIONS EXCEPT THAT THE PT HAS MEDICAL PROBLEMS INCLUDING (B)(6), CHRONIC CIRRHOSIS, METASTATIC CANCER OF THE LOW COLON, AND EXTREME OBESITY. THESE MEDICAL CONDITIONS COULD HAVE CONTRIBUTED TO THE PT'S REVISION. IN ADDITION TO THE LATE ONSET OF INFECTION THE STERILIZATION PROCESS FOR THE REPORTED DEVICES WAS VALIDATED IN ACCORDANCE WITH FDA REGULATIONS AND IOS STANDARDS TO A STERILITY ASSURANCE LEVEL (SAL) OF 1.0 X 10 (-6) OR BETTER. THE MFG LOTS SPECIFIED IN THIS COMPLAINT WERE PROCESSED ACCORDING TO THE VALIDATED STERILIZATION PROCESS PARAMETERS AND MET ALL THE ACCEPTANCE CRITERIA FOR STERILITY RELEASE. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE DEVICES CONTRIBUTED TO ANY PT INFECTION. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. SHOULD ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO A DEEP INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSYS FEMORAL STEM BEADED FULLCOAT LPH ZIMMER, INC. 42054800

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention TRILOGY LONGEVITY CROSSLINKED POLYETHYLENE LINER:| LOT #25752700 - MFG BY ZIMMER B.V.| VERSYS FEMORAL HEAD: CATALOG #00801803203,| TRILOGY ACETABULAR SHELL: CATALOG #65620006822,| CATALOG #00630506832, LOT #63417500| LOT #41586800