BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURAL KNEE II STEMMED TIBIAL BASEPLATE

    MDR report key: 2041102 · Received March 29, 2011

    Report

    Report Number
    1822565-2011-00763
    Event Type
    Injury
    Date Received
    March 29, 2011
    Report Date
    February 28, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: SURGICAL NOTES AND X-RAYS WERE NOT PROVIDED TO STUDY THE FIXATION. WITH THE AVAILABLE INFO, THE PROBABLE CAUSE FOR PT'S PAIN/SWELLING CANNOT BE DETERMINED. 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 AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT IS PRESENTING WITH PAIN AND SWELLING AND HAS BEEN ASPIRATED TO RULE OUT INFECTION. IT IS ALSO REPORTED THAT SHE HAS NOT REGAINED FULL MOBILITY IN HER LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURAL KNEE II STEMMED TIBIAL BASEPLATE KNEE PROSTHESIS JWH ZIMMER, INC. 61376223

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NATURAL KNEE GSF FEMORAL COMPONENT:| GENDER SOLUTIONS NATURAL KNEE FLEX PROLONG HIGHLY| CAT #00541401501, LOT #61372134| CAT #00542000801, LOT # 61048240| CROSSLINKED POLYETHYLENE ALL POLY PATELLA| CAT #00542801011, LOT #60853854| GENDER SOLUTIONS NATURAL KNEE FLEX PROLONG HIGHLY| CROSSLINKED POLYETHYLENE ARTICULAR SURFACE