BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS HIP SYSTEM FEMORAL STEM FIBER METAL MIDCOAT COLLARED

    MDR report key: 1241113 · Received November 21, 2008

    Report

    Report Number
    1822565-2008-00828
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 15, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY - THE STERILIZATION PROCESS FOR THE DEVICE WAS VALIDATED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE OF 10-6 OR BETTER. THE MANUFACTURING LOT SPECIFIED IN THIS COMPLAINT WAS PROCESSED ACCORDING TO THE VALIDATED STERILIZATION PROCESS PARAMETERS AND MET ALL OF THE ACCEPTANCE CRITERIA FOR STERILITY RELEASE. THEREFORE, IT IS UNLIKELY THAT THE SPECIFIED DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT INFECTION. NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2008, AND EXPLANTED AND THE FOLLLOWING MONTH, DUE TO INFECTION OF THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSYS HIP SYSTEM FEMORAL STEM FIBER METAL MIDCOAT COLLARED HIP PROSTHESIS KWY ZIMMER, INC. NA 60713117

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED| CATALOG# 00625006525| 00801802802| VERSYS HIP SYSTEM FEMORAL HEAD: CATALOG#| MANUFACTURED AT ZIMMER B.V. MANUFACTURING PONCE| TRILOGY ACETABULAR SYSTEM BONE SCREW SELF-TAPPING:| MANUFACTURED AT ZIMMER B.V. MANUFACTURING PONCE| TRILOGY ACETABULAR SYSTEM BONE SCREW SELF-TAPPING:| MANUFACTURED AT ZIMMER B.V. MANUFACTURING PONCE| TRILOGY ACETABULAR SYSTEM SHELL WITH CLUSTER| POLYETHYLENE LINER: CAT# 00630505828 LOT# 60853369| ZIMMER B.V. MANUFACTURING PONCE| HOLES: CATALOG# 00620005822| CATALOG# 00625006535