BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR NECK G2 12/14 NECK TAPER USE WITH +0 HEADS ONLY

    MDR report key: 9577386 · Received January 10, 2020

    Report

    Report Number
    0001822565-2020-00152
    Event Type
    Injury
    Date Received
    January 10, 2020
    Date of Event
    March 12, 2018
    Report Date
    May 15, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K063251
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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. AN ADDITIONAL MDR REPORT WAS FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001822565 - 2020 - 00961 STEM, 0001825034 - 2020 - 01203 LINER, 0001825034 - 2020 - 01204 SHELL.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: A1, A4, B3, B4, B5, B7, D7, D11, E1, G4, H2, H6 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.

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. OPERATIVE NOTES WERE PROVIDED FOR THE TWO STAGE REVISION SURGERY. THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO METALLOSIS, TISSUE DAMAGE, PERIPROSTHETIC FRACTURE AND FRACTURE, AND POLYETHYLENE FAILURE. PATIENT WAS PRESENTED WITH PAIN, XRAY CONFIRMED EROSION OF THE ACETABULAR LINER, CT AND MRI CONFIRMED NECROSIS OF THE VASUTUS LATERALIS WITH ABUNDANT FLUID INTRA-ARTICULAR AND DOWN THE LATERAL THIGH SUGGESTING INFECTION, ESR AND CRP. EDEMA WAS NOTED IN THE LATERAL TISSUES; BLACK TARRY OOZE FLUID WAS SENT FOR CULTURE SUSPECTED AS METALLOSIS. DRAINAGE AND DEBRIDEMENT WAS PERFORMED OF THE RIGHT THA WITH REMOVAL OF THE FEMORAL HEAD AND FRACTURED LINER. NECROSIS WAS NOTED OVER THE VASTUS LATERALIS. STEM WAS LEFT IN PLACE AS ANTIBIOTIC SPACERS AND FURTHER DEBRIDEMENT ARE PLANNED FOR THE PATIENT. SHELL WAS LEFT INTACT. DRAINS WERE PLACED. THE PATIENT UNDERWENT THE SECOND STAGE REVISION. BLOOD CULTURES RETURNED POSITIVE FOR MRSA BACTERIA, PATIENT HAD CONCURRENT LEFT SHOULDER INFECTION/PURULENCE. STEM AND SHELL FOUND WELL FIXED, PROXIMAL BONE FRAGMENTATION NOTED WITH THE GREATER TROCHANTER BURIED IN THE SOFT TISSUE. GROSSLY NECROTIC BONE NOTED AROUND FEMORAL COMPONENTS AND ANTERIOR FEMUR CRACKED IN THE PROCESS OF REMOVING THE STEM. METAL STAINED TISSUE AND SCAR TISSUE DEBRIDED FROM ACETABULUM. SCREW APPEARED TO HAVE WELDED TO ACETABULAR COMPONENT DUE TO THE FEMORAL HEAD ENGAGING WITH THE METAL ACETABULUM FROM THE LINER FRACTURING. UPON CUP EXTRACTION, SEVERE CAVITAY DEFECTS NOTED WITH MILD LOSS OF THE POSTERIOR WALL. ALL COMPONENTS REMOVED, SPACER PLACED. 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 · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE APPROXIMATELY 5 YEARS POST-IMPLANTATION DUE METALLOSIS, TISSUE DAMAGE, PERIPROSTHETIC FRACTURE AND INFECTION, POLYETHYLENE FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE APPROXIMATELY 5 YEARS POST-IMPLANTATION DUE TO METALLOSIS, TISSUE DAMAGE, PERIPROSTHETIC FRACTURE, INFECTION, POLYETHYLENE FAILURE AND A LARGE CAVITARY DEFECT OF THE ACETABULUM. TWO-PART SURGERY TO REMOVE ALL DEVICES AND REPLACE WITH ANTIBIOTIC SPACERS DUE TO INFECTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 00771300900 62309332 M/L TAPER KINECTIV STEM SIZE 9, EP-108524 921590 E-POLY 40MM +3 HIWALL LNR SZ24, 106054 884870 RAN/BUR RNGLC SHL 54MM SZ 24, 00801804002 62358028 FEMORAL HEAD. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY PATIENTS¿ LEGAL COUNSEL THAT THE PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE APPROXIMATELY 5 YEARS POST-IMPLANTATION DUE TO UNKNOWN REASONS. IT HAS ALSO BEEN NOTED THAT THE DEVICES HAVE ALLEGED TO CAUSE IN VIVO CORROSION. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36698 MODULAR NECK G2 12/14 NECK TAPER USE WITH +0 HEADS ONLY PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 62198159

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R SEE H10.