BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX POLY ARTICULAR SURFACE

    MDR report key: 2010534 · Received March 1, 2011

    Report

    Report Number
    1822565-2011-00472
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    December 9, 2010
    Report Date
    January 31, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: SURGICAL NOTES OF FIRST REVISION SURGERY ARE NOT AVAILABLE TO STUDY ANY DEVIATIONS IN THE SURGICAL PROCEDURE. THOUGH THE SECOND REVISION SURGICAL PROCEDURE REVEALS THAT THERE WAS CONSIDERABLE SCARRING FOUND THROUGHOUT THE KNEE, NOTHING IS CONCLUSIVE WITHOUT THE AVAILABILITY OF PRE-OP AND POST-OP X-RAYS. WITH THE AVAILABLE INFO, PROBABLE REASON FOR PT'S PAIN/INFECTION POST REVISION CANNOT BE DETERMINED. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED FOR SUSPECTED INFECTION. NO INFECTION WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS-FLEX POLY ARTICULAR SURFACE JWH ZIMMER, INC. 60813961

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention CATALOG # 00599401591, LOT # 60800089| COMPONENT, CATALOG # 00598003702, LOT # 60831351,| CONSTRAINED CONDULAR (LCCK) FEMORAL COMPONENT| BV, (B)(4)| CATALOG #00598801215, LOT #60629307, MFG AT ZIMMER| NEXGEN COMPLETE KNEE SOLUTION FEMORAL AUGMENT| NEXGEN COMPLETE KNEE SOLUTION STEMMED TIBIAL| NEXGEN COMPLETE KNEE SOLUTION ALL POLY PATELLA,| NEXGEN COMPLETE KNEE SOLUTION STEM EXTENSION| MFG AT ZIMMER BV, (B)(4)| NEXGEN COMPLETE KNEE SOLUTION STEM EXTENSION,| NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-| (B)(4)| CATALOG #00597206535, LOT #60887254, MFG AT ZIMMER| CATALOG # 00598801013, LOT # 60518070| SCREW, CATALOG # 00598809200, LOT # 60913348