BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS POROUS FEMORAL COMPONENT

    MDR report key: 2023525 · Received March 16, 2011

    Report

    Report Number
    1822565-2011-00640
    Event Type
    Injury
    Date Received
    March 16, 2011
    Report Date
    February 17, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE FEMORAL COMPONENT AND PATELLAR COMPONENT ARE COMPATIBLE. NEITHER X-RAYS OR OP-NOTES WERE PROVIDED. BASED UPON THE AVAILABLE INFORMATION, A CAUSE FOR THE REPORTED PAIN CANNOT BE DETERMINED. THERE ARE NO INDICATIONS, HOWEVER, OF PRODUCT CONTRIBUTION. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS FOR THE PATELLA COMPONENT DID NOT FIND ANY DEVIATIONS OR ANOMALIES. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE FEMORAL COMPONENT 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 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 AFTER SURGERY, THE PHYSICIAN PULLED ON THE PT'S LEG AND PAIN HAS BEEN EXPERIENCED SINCE THIS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS POROUS FEMORAL COMPONENT JWH ZIMMER, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NEXGEN ALL POLY PATELLA, CATALOG #00597206535| PONCE, PUERTO RICO| LOT #60959030, MANUFACTURED AT ZIMMER B.V.,