BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEM EXTENSION STRAIGHT

    MDR report key: 2041103 · Received March 29, 2011

    Report

    Report Number
    1822565-2011-00782
    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 ARE AVAILABLE AND INDICATE NO DEVIATIONS IN THE SURGICAL PROCEDURE FOLLOWED. THE PRE-OP AND POST OP X-RAYS ARE NOT AVAILABLE TO ANALYZE THE FIXATION. HOWEVER, THE PRODUCTS USED ARE FOUND TO BE IN PROPER COMBINATION. PT DEMOGRAPHICS ARE ALSO NOT AVAILABLE FOR ANALYSIS. WITH THE AVAILABLE INFO, PROBABLE CAUSE FOR PT'S PAIN CANNOT BE DETERMINED. REVIEW OF THE DEVICE HISTORY RECORDS WAS 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 INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT IS PRESENTING WITH PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN STEM EXTENSION STRAIGHT JWH ZIMMER, INC. 60677119

    Patients

    Seq Age Sex Outcome Treatment
    1 Other UNK ARTICULAR SURFACE: CAT # UNK, LOT # UNK| NEXGEN TIBIAL BLOCK: CAT#00598804027,LOT#60200120| LOT#60707737 MFG BY ZIMMER B.V. PONCE, PUERTO RICO| NEXGEN STEMMED TIBIAL COMPONENT: CAT #00598003702