BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PEGGED TIBIAL COMPONENT SIZE 3

    MDR report key: 2831714 · Received November 9, 2012

    Report

    Report Number
    1822565-2012-02308
    Event Type
    Injury
    Date Received
    November 9, 2012
    Date of Event
    April 13, 2011
    Report Date
    August 15, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK933785
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY ¿ NEITHER SURGICAL NOTES NOR X-RAYS WERE PROVIDED, THEREFORE FIT AND ORIENTATION COULD NOT BE EVALUATED. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL OR TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNK. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. EVAL: 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 ADD¿L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: FEMUR CATALOG 00575001405 LOT UNKNOWN; UNKNOWN 10MM ARTICULAR SURFACE; UNKNOWN 29 PATELLA.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NEXGEN FEMUR SIZE D LEFT CATALOG 00575001405, LOT 60700122; ARTICULAR SURFACE 10MM CATALOG 90597003010, LOT 60726081; ALL POLY PATELLA CATALOG 00597206529, LOT 60721030; UNKNOWN PALACOS CEMENT.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED. SURGICAL NOTES WERE PROVIDED AND CORRECT SURGICAL TECHNIQUES WERE PERFORMED FOR THE PRIMARY ((B)(6) 2007) AS WELL ON THE REVISION ((B)(6) 2011). OPERATIVE NOTES FROM THE REVISION SURGERY STATE THAT THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING. THE INDICATIONS FOR SURGERY STATE THAT X-RAYS SHOWED LOOSENING OF THE TIBIAL TRAY. DURING THE SURGERY THE TIBIAL COMPONENT WAS STATED TO BE LOOSE, PRIMARILY AT THE LATERAL SIDE OF THE TRAY. ON REVISION, THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN THE ASSOCIATED RISK DOCUMENTATION. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED APPROXIMATELY FOUR YEARS POST IMPLANTATION DUE TO ASEPTIC LOOSENING. OPERATIVE NOTES PROVIDED NOTED LOOSENING OF THE TIBIAL COMPONENT, PRIMARILY ON THE LATERAL SIDE. ALL COMPONENTS WERE REMOVED AND REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PEGGED TIBIAL COMPONENT SIZE 3 JWH ZIMMER, INC. N/A 60677523

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention