BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-MODULAR PEGGED GLENOID

    MDR report key: 6477062 · Received April 10, 2017

    Report

    Report Number
    0001825034-2017-02426
    Event Type
    Injury
    Date Received
    April 10, 2017
    Date of Event
    February 1, 2017
    Report Date
    September 21, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK992119
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANT DATE WAS IN 2006. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT/ONSET - UNKNOWN DATE IN (B)(6) 2017. MEDICAL PRODUCT: BIO-MODULAR SHOULDER HUMERAL WITH ALIGNMENT HOLE, CATALOG#: 11-113709, LOT#: 874110; BIO-MODULAR SHOULDER GLENOID COMPONENT, CATALOG#: 113722, LOT#: 074400. 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. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE REPORTED DEVICE (BIO-MODULAR SHOULDER SYSTEM ¿ GLENOID) WAS RETURNED, STEM AND HUMERAL HEAD WERE ALSO RETURNED. BECAUSE THE GLENOID WOULD NATURALLY BECOME DEFORMED TO SOME EXTENT DURING IMPLANTATION AND EXPLANTATION, DIMENSIONAL ANALYSIS WAS NOT PERFORMED. EACH OF THE RETURNED ITEMS SHOWS SIGNIFICANT COSMETIC DAMAGE (SCRATCHES AND GOUGES). THIS IS LIKELY FROM IMPLANTATION AND / OR EXPLANTATION. THE PEGGED SURFACE OF THE GLENOID SHOWS VERY LITTLE (IF ANY) CEMENT RESIDUE. THIS CONFIRMS THE COMPLAINT OF LOOSENING. WHILE IT IS NOT KNOWN WHETHER THE SURGICAL TECHNIQUE WAS FOLLOWED, IT CAN BE INFERRED THAT IT WAS BASED ON THE FACT THAT THE BEARING SURFACE SHOWS EVEN WEAR, AND THE FACT THAT THERE ARE NO MEDICAL RECORDS INDICATING PROBLEMS DURING THE NEARLY TEN (10) YEARS BETWEEN IMPLANTATION AND REVISION. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. COMPLAINT HISTORY REVIEW DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. BASED ON THE REVIEW OF MANUFACTURING RECORDS AND COMPLAINT HISTORY, THE DEVICE IS BELIEVED TO HAVE BEEN CONFORMING TO PRINT WHEN LEAVING ZIMMER BIOMET CONTROL. THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. APPROXIMATELY 11 YEARS SUBSEQUENT, THE PATIENT WAS REVISED DUE TO GLENOID COMPONENT LOOSENING. NO FURTHER SERIOUS INJURY HAS BEEN REPORTED, AND NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259081 BIO-MODULAR PEGGED GLENOID PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 004290

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R