BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLECT.NO.QAS KNEE IMPLANTS VEGA

    MDR report key: 9800913 · Received March 6, 2020

    Report

    Report Number
    2916714-2020-00063
    Event Type
    Injury
    Date Received
    March 6, 2020
    Date of Event
    October 27, 2017
    Report Date
    May 26, 2020
    Manufacturer
    AESCULAP AG
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    GENERAL INFORMATION: WE RECEIVED A COMPLAINT FROM THE SEBASTIAN HOSPITAL, SEBASTIAN, REGARDING VEGA COMPONENTS. THERE ARE NO DEVICES AVAILABLE FOR INVESTIGATION. WE DO NOT KNOW EXACTLY THE REFERENCE CODE, AS WELL AS THE BATCH NUMBER OF THE LEADING AND INVOLVED COMPONENTS. THERE ARE NO X-RAY FIGURES AVAILABLE. THIS CASE IS IN RELATION TO CASE (B)(4) (SAME PATIENT-> OTHER KNEE). ASSOCIATED MEDWATCH REPORTS 9610612-2020-00046 ((B)(4), AE-QAS-K521-56) - RIGHT KNEE. 9610612-2020-00047 ((B)(4), AE-QAS-K521-56) - LEFT KNEE. CONSEQUENCES FOR THE PATIENT: POST-OPERATIVE MEDICAL INTERVENTION WAS NECESSARY. REVISION SURGERY. INVESTIGATION: NO PRODUCT AT HAND . THEREFORE A FAILURE DESCRIPTION IS NOT POSSIBLE. BATCH HISTORY REVIEW: A REVIEW OF THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS IS NOT POSSIBLE BECAUSE THE MATERIAL NUMBER AS WELL AS THE BATCH NUMBER IS UNKNOWN. THE DEVICE QUALITY AND MANUFACTURING HISTORY HAS BEEN CHECKED FOR THE MENTIONED COMPONENTS (UP TO NOW THERE IS NO CLEAR EVIDENCE THAT THIS DEVICES WERE USED): PRIMARY SURGERY: RIGHT KNEE. NX111 (PS PE INSERT T1/T1+, 12MM); 51942888. NX042 (UNIVERSAL PATELLA P2); 51944942. NX031Z (PS FEMUR CEMENTED F5N RT); 51948275. NN260P (PEEK PLUG F/ TIBIA); 51904876. NX051Z (PS TIBIA CEMENTED T1); 51967092. AND FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THESE BATCHES. CONCLUSION AND ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE IT IS NOT POSSIBLE TO DETERMINE A POSSIBLE ROOT CAUSE FOR THE FAILURE. RATIONALE: IN THE LIGHT OF THE LITTLE INFORMATION RECEIVED AND DUE THE CIRCUMSTANCE THAT WE DID NOT RECEIVED THE COMPLAINED DEVICES IT IS NOT POSSIBLE TO DETERMINE A ROOT CAUSE FOR THE MENTIONED FAILURE. CORRECTIVE ACTION: A PRODUCT SAFETY CASE (PSC) WAS OPENED. ANY ACTION REGARDING CAPA WILL BE ADDRESSED WITH THIS CASE.

    Description of Event or Problem · 0

    NO UPDATES PROVIDED.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH KNEE IMPLANTS VEGA. IT WAS REPORTED THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED BILATERAL KNEE PAIN, DIFFICULTY WALKING, AND LOOSENING OF THE IMPLANTS, WHICH RESULTED IN A REVISION SURGERY FOR THE RIGHT KNEE. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2013 AND THE REVISION SURGERY OCCURRED IN (B)(6) 2017 (RIGHT KNEE). IT IS UNKNOWN WHICH COMPONENTS WERE REPLACED DURING THE RIGHT KNEE REVISION AND WHAT PARTS WERE USED FOR THE REVISION SURGERY. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME; IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. THE ADVERSE EVENT/MALFUNCTION IS FILED UNDER (B)(4). THE FOLLOWING PRODUCTS WERE LISTED IN THE PATIENT'S MEDICAL RECORDS: PRIMARY SURGERY: RIGHT KNEE, NX111 (PS PE INSERT T1/T1+, 12MM); 51942888, NX042 (UNIVERSAL PATELLA P2); 51944942, NX031Z (PS FEMUR CEMENTED F5N RT); 51948275, NN260P (PEEK PLUG F/ TIBIA); 51904876, NX051Z (PS TIBIA CEMENTED T1); 51967092. CEMENT: ZIMMER PALACOS RADIOPAQUE CEMENT. ASSOCIATED MEDWATCH REPORT: 9610612-2020-00047 ((B)(4) AE-QAS-K521-56) - LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264612 COLLECT.NO.QAS KNEE IMPLANTS VEGA PREVIOUSLY REPORTED JWH AESCULAP AG AE-QAS-K521-56

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention