BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM ACETABULAR COMPONENT 56/50 CODE P

    MDR report key: 3875196 · Received May 30, 2014

    Report

    Report Number
    9613350-2014-03581
    Event Type
    Other
    Date Received
    May 30, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVED DEVICES OR X-RAYS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. BASED ON AN EXTENSIVE INVESTIGATION OF EVENTS, REPORTED FROM SEVERAL USER FACILITIES OUTSIDE THE USA, ZIMMER IDENTIFIED THAT THE MOST PROBABLE CAUSE FOR THE OUTCOME OBSERVED WAS A LOOSE OR UNSTABLE CUP THAT RESULTED FROM USE OF SURGICAL TECHNIQUES NOT CONSISTENT WITH THE MANUFACTURER'S RECOMMENDATIONS. AS A CORRECTIVE ACTION, A RETRAINING PROGRAM FOR USERS OUTSIDE THE USA WAS INITIATED IN NOVEMBER 2009 AND REPORTED TO THE NATIONAL COMPETENT AUTHORITIES AS REQUIRED. THE DUROM CUP REPORTED IN THIS CASE IS NOT MARKETED IN THE USA. A SIMILAR CUP, COMPATIBLE WITH THE METASUL LDH FEMORAL HEAD, IS CLEARED IN THE USA AND A CORRECTIVE ACTION FOR THIS PRODUCT WAS REPORTED TO THE FDA IN JULY 2008 AS NOTIFICATION Z-2415/2426-2008. SINCE THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTIVE ACTION THERE WILL BE NO FURTHER INVESTIGATION. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    SINCE THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTIVE ACTION WHICH WAS REPORTED TO THE FDA IN JULY 2008 AS CORRECTION Z-2415/2426-2008, THERE WILL BE NO FURTHER INVESTIGATION AND ZIMMER (B)(4) WILL CLOSE THIS CASE ONCE AGAIN. (B)(4).

    Description of Event or Problem · 1

    IT HAS NOW BEEN REPORTED THAT THE PATIENT WAS IMPLANTED A DUROM ACETABULAR COMPONENT 56/50 CODE P. THIS IS A BILATERAL CLAIM.

    Description of Event or Problem · 1

    A PRODUCT LIABILITY CLAIM WAS RAISED. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A DUROM ACETABULAR COMPONENT 56/50 CODE P ON THE RIGHT SIDE OF (B)(6) 2006. CURRENTLY, THE PATIENT IS BEING MONITORED DUE TO UNKNOWN REASONS. LEFT COMPLAINT: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318739 DUROM ACETABULAR COMPONENT 56/50 CODE P DUROM ACETABULAR COMPONENT KWA ZIMMER GMBH N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other