BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSYS HIP SYSTEM FEMORAL STEM BEADED FULLCOAT COLLARED

    MDR report key: 1113317 · Received August 12, 2008

    Report

    Report Number
    1822565-2008-00509
    Event Type
    Malfunction
    Date Received
    August 12, 2008
    Date of Event
    June 3, 2005
    Report Date
    July 17, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE WAS IN VIVO FOR APPROXIMATELY 10 MONTHS BEFORE THE ALLEGED EVENT OCCURRED. THE EVENT WAS RESOLVED WITHOUT SURGICAL INTERVENTION 2 MONTHS SUCCEEDING THE INITIAL REPORT OF THE EVENT. SURGERY NOTES, X-RAYS IMAGES POST-SURGERY AND FROM SUCCESSIVE PATIENT VISITS ARE UNAVAILABLE. THE MATING FEMORAL HEAD AND ACETABULAR SHELL AND LINER COMPONENTS USED ARE UNKNOWN. IT IS UNKNOWN IF THE FEMORAL STEM WAS IMPLANTED IN THE CORRECT ORIENTATION AND WITH THE CORRECT FIT. THE INSTRUMENT USED DURING SURGERY ARE UNKNOWN. IT IS UNKNOWN IF THE WIRE WAS USED DUE TO FEMORAL FRACTURE OR TO PREVENT FEMORAL FRACTURE. THE FEMORAL PAIN CAN BE DUE TO ONE OR A COMBINATION OF THE FOLLOWING MECHANISMS: FEMORAL FRACTURE DURING IMPLANTATION, FEMORAL STEM ROTATIONAL MISALIGNMENT WITHIN REAMED CANAL, SMALLER FEMORAL STEM SIZE THAN NECESSARY FOR THE PATIENT, SOFT TISSUE IMPINGEMENT/RUBBING ON WIRES, EXTENT OF SOFT TISSUE TENSION, REHABILITATION TREATMENT PLAN AND COMPLIANCE, PHYSICAL ADAPTATION TO IMPLANT. CAUSE CANNOT BE DEFINITIVELY DETERMINED. NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. 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 AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2004. THE FOLLOWING YEAR, THE PATIENT PRESENTED WITH FEMORAL PAIN AT THE PROXIMAL FEMORAL CABLES. PAIN RESOLVED WITHOUT FURTHER SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSYS HIP SYSTEM FEMORAL STEM BEADED FULLCOAT COLLARED HIP PROSTHESIS KWY ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR