BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3761956 · Received April 21, 2014

    Report

    Report Number
    0002249697-2014-01372
    Event Type
    Injury
    Date Received
    April 21, 2014
    Date of Event
    July 2, 2012
    Report Date
    March 26, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT WAS ADDED TO THE COMPLAINT AFTER THE INITIAL MEDWATCH WAS SUBMITTED. CAT. NO.: 61979010, SIMPLEX P - US TOBRA FD 10-PK, LOT CODE: MBT013. CAT. NO.: 61979010, SIMPLEX P - US TOBRA FD 10-PK, LOT CODE: MCT026. THE PATIENT IS (B)(6) INCHES IN HEIGHT. AN EVENT REGARDING PAIN AND SWELLING INVOLVING A TRIATHLON PS X3 TIBIAL INSERT WAS REPORTED. THE EVENT WAS CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED MEDICAL RECORDS AND/OR X-RAYS BY A CLINICAL CONSULTANT CONCLUDED: ¿[¿] FURTHER WORKUP OF PERSISTENT DISCOMFORT IN BOTH KNEES IS NOT DOCUMENTED BEYOND (B)(6) 2014. THERE IS NO EVIDENCE OF FACTORS OF FAULTY PROSTHETIC DESIGN, MANUFACTURING, OR MATERIALS BEING RESPONSIBLE FOR THIS CLINICAL SITUATION. DEVICE HISTORY REVIEW: INDICATED ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE EXACT CAUSE OF THE PAIN AND SWELLING COULD NOT BE DETERMINED. MEDICAL REVIEW INDICATED ¿FURTHER WORKUP OF PERSISTENT DISCOMFORT IN BOTH KNEES IS NOT DOCUMENTED BEYOND (B)(6) 2014." FURTHERMORE, ¿THERE IS NO EVIDENCE OF FACTORS OF FAULTY PROSTHETIC DESIGN, MANUFACTURING, OR MATERIALS BEING RESPONSIBLE FOR THIS CLINICAL SITUATION."

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN STRYKER LEFT KNEE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CONTINUES TO EXPERIENCE PAIN AFTER HER REVISION SURGERY. PATIENT REPORTED THAT HER LEFT KNEE IS SWOLLEN THE SIZE OF A GRAPEFRUIT. SHE STILL WALKS WITH A CANE AND TIME TO TIME SHE FALLS TO THE POINT WHERE SHE SPRAINED HER ANKLE AS A RESULT OF HER WEAK KNEE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CONTINUES TO EXPERIENCE PAIN AFTER HER REVISION SURGERY. PATIENT REPORTED THAT HER LEFT KNEE IS SWOLLEN THE SIZE OF A GRAPEFRUIT. SHE STILL WALKS WITH A CANE AND TIME TO TIME SHE FALLS TO THE POINT WHERE SHE SPRAINED HER ANKLE AS A RESULT OF HER WEEK KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240015 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH MKRK09

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other