BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TESS HUMERAL INSERT TH 8 DIA36 S0

    MDR report key: 6231387 · Received January 6, 2017

    Report

    Report Number
    3006946279-2017-00012
    Event Type
    Injury
    Date Received
    January 6, 2017
    Report Date
    June 29, 2017
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    KWS
    PMA / PMN Number
    PK060694
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. DATE OF BIRTH, MONTH AND DAY - NI. DATE OF EVENT ¿ NI. MEDICAL PRODUCT - TESS HUM REVERSE COROLLA S0, CATALOG#: P1700430 LOT#: 0001135306. THERAPY DATE - UNKNOWN. THIS PRODUCT IS MANUFACTURED BY (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K060694.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING FILED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED. INVESTIGATION RESULTS CONCLUDED THAT SMALLER SIZES OF THIS COMPONENT MAY REQUIRE MORE FORCE UPON IMPACTION, BECAUSE THE SMALLER COMPONENTS ARE LESS FLEXIBLE. THE RETURNED DEVICE WAS ANALYZED AND FOUND CONFORMING TO SPECIFICATIONS. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND THAT WERE RELEVANT TO THE REPORTED EVENT. THE ROOT CAUSE OF THE EVENT IS THE DESIGN OF THE COMPONENT, WHICH DOES NOT TAKE INTO ACCOUNT THAT SIZE HAS AN EFFECT ON ELASTICITY. CORRECTIVE ACTION HAS BEEN INITIATED TO ADDRESS THE REPORTED ISSUE. 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

    DURING A SHOULDER ARTHROPLASTY, THE HUMERAL INSERT WOULD NOT ASSEMBLE PROPERLY WITH THE COROLLA. A NEW INSERT AND COROLLA WERE USED TO COMPLETE THE PROCEDURE WITHOUT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14187 TESS HUMERAL INSERT TH 8 DIA36 S0 PROSTHESIS, SHOULDER KWS BIOMET FRANCE S.A.R.L. N/A 0001138458

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention