BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD POSTERIOR STABILIZED TIBIAL BEARING

    MDR report key: 6946064 · Received October 12, 2017

    Report

    Report Number
    0001825034-2017-08332
    Event Type
    Injury
    Date Received
    October 12, 2017
    Date of Event
    September 15, 2017
    Report Date
    April 19, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK042757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING SUPPORTED TO REPORT ADDITIONAL INFORMATION CONCOMITANT PRODUCTS- 185100 NAME: VNGD SSK PS TIB BRG 10X79/83 LOT: 539800; 141656 NAME: BMT SPLINED KNEE STM 16X120 LOT: 645660; 183326 NAME: VNGD SSK INTLK FMRL 70 LT LOT: 181120; 184166 NAME: VNGD POST FEM AUG 70X5 LL/RM LOT: 668840; 184126 NAME: VNGD DIST FEM AUG 70X5 LL/RM LOT: 897770; 184146 NAME: VNGD POST FEM AUG 70X5 RL/LM LOT: 854490; 141516 NAME: BIOMET ILOK STEM TIB TRAY 83MM LOT: 081270; 184607 NAME: RGX CONE AUG POR TI 40MM MED LOT: 004300; 141652 NAME: BMT SPLINED KNEE STM 12X120 LOT: 992860. REPORTED EVENT WAS CONFIRMED THROUGH RADIOGRAPHS RECEIVED. PRODUCT WAS NOT RETURNED FOR EVALUATION. X-RAY REVIEW REPORT INDICATES PRESENTS OF LUNCENCY SURROUNDING THE FEMORAL STEM. OSTEOPENIA. NORMAL ANATOMY. NO FRACTURE SEEN. NO EVIDENCE OF WEAR OR DEBRIS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: BIOMET SPLINED KNEE STEM, CAT#: 141656 LOT#: 645660. VANGUARD SSK INTERLOK FEMORAL, CAT#: 183326 LOT#: 181120. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-08332, 0001825034-2017-08334, 0001825034-2017-08335. PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTION AND ADDITIONAL INFORMATION. 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 WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS PAIN, OSTEOLYSIS AND LOOSENING OF THE STEM AND FEMORAL. THE POLYETHYLENE BEARING ALSO SHOWED SIGNS OF PITTING AND WEAR. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS ALSO REPORTED THERE WAS A SLIGHT DELAY IN TRYING TO REPAIR A SLIGHT FRACTURE DUE TO BONE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724335 VANGUARD POSTERIOR STABILIZED TIBIAL BEARING PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 539800

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R