BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD SSKPSC TIBIAL BEARING S 12X63/67

    MDR report key: 6731432 · Received July 21, 2017

    Report

    Report Number
    0001825034-2017-05037
    Event Type
    Injury
    Date Received
    July 21, 2017
    Date of Event
    June 27, 2017
    Report Date
    November 9, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK042757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED. (B)(6), FEMALE. PRODUCT PROBLEM, HOSPITALIZATION. EVENT DATE (B)(6) 2017. IT WAS REPORTED FOLLOWING AN INITIAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO INSTABILITY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. THE PATIENT'S BONE QUALITY IS FAIR. VANGUARD SSKPSC TIBIAL BEARING S 12X63/67, JWH, CATALOG NUMBER-183822, LOT NUMBER- 936900, EXPIRATION DATE- AUG 31, 2014, IMPLANT (B)(6) 2011. EXPLANT (B)(6) 2017. (B)(6) (B)(4). REC'D BY MFR: JUL 12, 2017. K042757. CONCOMITANT PRODUCTS: BIOMET SPLINED KNEE STEM 14X80, CATALOG # 141614, LOT # 555860; VANGUARD DISTAL FEMORAL AUGMENT 60X5 RL/LM, CATALOG # 184102, LOT # 220050; VANGUARD SSK PSC INTERLOK FEMORAL 60 LT, CATALOG # 183322, LOT # 907980; VANGUARD DISTAL FEMORAL AUGMENT 60X5 LL/RM CATALOG # 184122, LOT # 816540; BIOMET SPLINED KNEE STEM 80X12MM, CATALOG # 141612, LOT # 167940; BIOMET OFFSET TIBIAL TRAY 67MM, CATALOG # 141482, LOT # 758790; BIOMET OFFSET TIBIAL TRAY ADAPTOR 5MM, CATALOG # 141491, LOT # 693900; BIOMET SERIES A PATELLA W/WR THN 28 1 PEG, CATALOG # 184722, LOT # 703820. 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: 0001825034-2017-06296, 0001825034-2017-06297, 0001825034-2017-06298, 0001825034-2017-06299.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE IS NOT EXPECTED FOR RETURN CURRENTLY, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED FOLLOWING AN INITIAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO INSTABILITY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT KNEE ARTHROPLASTY ON AN UNKNOWN DATE, SUBSEQUENTLY, THE PATIENT UNDEWENT A REVISION FOR UNKNOWN REASON. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS, HOWEVER NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511642 VANGUARD SSKPSC TIBIAL BEARING S 12X63/67 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 936900

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R UNKNOWN BEARING COMPONENT| UNKNOWN TIBIAL COMPONENT