BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER FEMORAL HEAD

    MDR report key: 4142601 · Received September 30, 2014

    Report

    Report Number
    2648920-2014-00258
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 2, 2014
    Manufacturer
    ZIMMER
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE DEVICES WERE NOT RETURNED FOR REVIEW, SO THEIR CONDITIONS ARE UNK. OPERATIVE NOTES ARE UNAVAILABLE FOR REVIEW; ASSEMBLY TECHNIQUE OF THE FEMORAL HEAD IS UNK. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO; HOWEVER, NO INFO HAS BEEN RECEIVED TO DATE. X-RAYS POSTOPERATIVELY AND AFTER HEAD DISASSOCIATION ARE PROVIDED; A CERCLAGE WIRE IS PRESENT. IT IS UNK IF THE PT EXPERIENCED ANY TRAUMATIC EVENT OR VIOLATED ANY POST OPERATIVE THA INDICATIONS CAUSING OR CONTRIBUTING TO THE DISASSOCIATION. THE LINER USED IS A CONSTRAINED LINER, WHICH HOLDS THE FEMORAL HEAD IN THE SOCKET BY USE OF A CONSTRAINING RING. CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVAL CODES: IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OR PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THE PT WAS REVISED DUE TO THE HEAD DISASSOCIATING FROM THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608127 ZIMMER FEMORAL HEAD JDI ZIMMER 62661593

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention ZIMMER POROUS FEMORAL STEM, CAT#65764501000,| LOT#60876354 MANUFACTURED BY ZIMMER (B)(4)