BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER BIPOLAR ACETABULAR SHELL

    MDR report key: 2023549 · Received March 16, 2011

    Report

    Report Number
    1822565-2011-00646
    Event Type
    Injury
    Date Received
    March 16, 2011
    Report Date
    February 17, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORIGINAL HEMI-ARTHROPLASTY WAS PERFORMED DUE TO FEMORAL NECK FRACTURE THAT LED TO AVASCULAR NECROSIS OF THE FEMORAL HEAD. NO PT DEMOGRAPHICS WERE PROVIDED. THREE POST-OPERATIVE X-RAYS WITH RADIOLOGICAL REPORTS AND SURGICAL NOTES FROM THE HEMI-ARTHROPLASTY WERE PROVIDED. THE SURGICAL NOTES REPORT THAT THERE WAS NO COMPLICATIONS. ONE RADIOLOGICAL REPORT NOTED THAT A SINGLE SCREW REMAINED IN THE FEMORAL NECK. ALL X-RAYS APPEAR NORMAL. THE CONDITION OF THE DEVICES IS UNK. IT IS ALSO UNK IF THE PT FOLLOWED THE PROPER REHABILITATION PROTOCOLS. BASED ON THE INFORMATION AVAILABLE, A DEFINITIVE CAUSE FOR THIS ISSUE CANNOT BE DETERMINED WITH CERTAINTY. 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 REC'D, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT IS EXPERIENCING RIGHT HIP PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER BIPOLAR ACETABULAR SHELL HIP PROSTHESIS JDI ZIMMER, INC. 60620252

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ZIMMER TOTAL HEAD, NEUTRAL NECK| CATALOG #721026000, LOT #60950855| CATALOG #735402204, LOT #60903198| ZIMMER NATURAL-HIP SYSTEM POROUS STEM