BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AS TIBIA OFFSET STEM D14X132 CEMENTLESS

    MDR report key: 11334224 · Received February 16, 2021

    Report

    Report Number
    2916714-2021-00018
    Event Type
    Injury
    Date Received
    February 16, 2021
    Report Date
    December 29, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    JWH
    UDI-DI
    04046963176396
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: AS OF THE DATE OF THIS REPORT THE COMPLAINT PRODUCT WAS NOT PROVIDED FOR INVESTIGATION. THEREFORE, A THOROUGH INVESTIGATION IS NOT POSSIBLE. ON THE BASIS OF THE CURRENT INFORMATION AND WITHOUT THE PRODUCT FOR INVESTIGATION, A CLEAR CONCLUSION CANNOT BE DRAWN. AT THAT TIME WE ASSUME THAT THE MENTIONED PROBLEMS ARE NOT PRODUCT RELATED. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER AND WERE FOUND TO BE ACCORDING TO OUR SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. REVIEW OF THE COMPLAINT HISTORY REVEALED THAT NO SIMILAR COMPLAINTS HAVE BEEN FILED AGAINST PRODUCTS FROM THIS BATCH NUMBER. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. IN THE EVENT THAT THE COMPLAINT PRODUCT WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.

    Description of Event or Problem · 0

    NO UPDATES. CONCOMITANT PRODUCTS: NR142M KIR # 52098006; NR466Z LOT # 52091106; NR077Z LOT # 52259916; NR436Z LOT # 52166188; NR006Z LOT # 52184799; NR400Z LOT # 52337135.

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION OR EVALUATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH COLUMBUS KNEE IMPLANT(S). ACCORDING TO THE COMPLAINT, THE PATIENT FELL OFF A LADDER AND THE IMPLANTS MAY BE REVISED IN THE FUTURE; THE PATIENT IS BEING FOLLOWED BY A PHYSICIAN FOR ANY FURTHER TREATMENT. THE INTIAL IMPLANTATION WAS PERFORMED ON (B)(6) 2018 AND THE REVISION WAS NOT YET PLANNED OR SCHEDULED. HE FELL OFF 16 FOOT LADDER. THERE IS NOW LOOSENING AT MEDIAL TIBIA WITH SEVERE BONE SPLINTER PAIN 3 INCHES DOWN, MEDIAL WITH PAD SCUFFING - FLOATER IS PRESENT. JOINT IS TOO TIGHT, HOWEVER, MAXIMUM BEND IS AT ACCEPTABLE RANGE ACCORDING TO CURRENT TREATING DOCTOR. TIBIA NOW REPORTEDLY HAS OSTEOPOROSIS. SHARP PAIN BOTH ANTERIOR HORIZONTAL PLANT OF PATELLA; PERHAPS SMALLER THICKNESS PAD REPLACEMENT WOULD FIX PRESSURE PROBLEM. PATIENT IS EXTREMELY BOW-LEGGED, SO LONG STEM IS TORQUEING TIBIA WITH BONE PAIN. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER XC REFERENCE (B)(4). CONCOMITANT PRODUCTS: NR142M KIR # 52098006, NR466Z LOT # 52091106, NR077Z LOT # 52259916, NR436Z LOT # 52166188, NR006Z LOT # 52184799, NR400Z LOT # 52337135.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231036 AS TIBIA OFFSET STEM D14X132 CEMENTLESS KNEE ENDOPROSTHETICS JWH AESCULAP AG NR184Z 52330185 04046963176396

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other NR006Z| NR077Z| NR142M| NR400Z| NR436Z| NR466Z