BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSS NON-MOD PROX TIB 7CM15X150

    MDR report key: 8676185 · Received June 6, 2019

    Report

    Report Number
    0001825034-2019-02453
    Event Type
    Malfunction
    Date Received
    June 6, 2019
    Report Date
    October 14, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K002757
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED PACKAGING DAMAGE EVENT WAS CONFIRMED VIA VISUAL EXAMINATION. IT WAS IDENTIFIED THE PACKAGING WAS DAMAGED IN TRANSIT. DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED WITH NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES IDENTIFIED. ROOT CAUSE IS ATTRIBUTED TO TRANSIT DAMAGE. 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

    NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORTING.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR'S WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT(S): 0001825034 - 2019 - 02451, 0001825034 - 2019 - 02452, 0001825034 - 2019 - 02454, 0001825034 - 2019 - 02455. CONCOMITANT MEDICAL PRODUCTS: PRIMARY DI# (B)(4), 151847, OSS 23CM TAPERED DIAPH SEGMENT, LOT 370180; PRIMARY DI# (B)(4), 151842, OSS 13CM TAPERED DIAPH SEGMENT, LOT 294250; PRIMARY DI# (B)(4), 150442, OSS NON-MOD PROX TIB 7CM15X150, LOT 024600; PRIMARY DI# (B)(4), 150439, OSS NON-MOD PROX TIB 7CM 9X150, LOT 608940; PRIMARY DI# (B)(4), 150439, OSS NON-MOD PROX TIB 7CM 9X150, LOT 108790. 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 DURING THE DISTRIBUTION PROCESS PACKAGING DAMAGE WITH STERILITY BARRIER POTENTIALLY COMPROMISED WAS IDENTIFIED. NO PATIENT OR SURGICAL INVOLVEMENT. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467701 OSS NON-MOD PROX TIB 7CM15X150 PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. 024600

    Patients

    Seq Age Sex Outcome Treatment
    1