BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSS 13CM TAPERED DIAPH SEGMENT

    MDR report key: 8773095 · Received July 9, 2019

    Report

    Report Number
    0001825034-2019-02925
    Event Type
    Malfunction
    Date Received
    July 9, 2019
    Report Date
    October 23, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    K141331
    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. THESE PRODUCTS WERE LIKELY CONFORMING WHEN THEY LEFT ZIMMER BIOMET CONTROL. 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 MDRS WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034 - 2019 - 02923, 0001825034 - 2019 - 02924. CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: 150474, LOT NUMBER: 358290, ITEM NAME: OSS 23CM DIAPHYSEAL SEGMENT, (B)(4). ITEM NUMBER: 150474, LOT NUMBER: 190220, ITEM NAME: OSS 23CM DIAPHYSEAL SEGMENT, (B)(4). ITEM NUMBER: 151842, LOT NUMBER: 558140, ITEM NAME: OSS 13CM TAPERED DIAPH SEGMENT, (B)(4). 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
    567630 OSS 13CM TAPERED DIAPH SEGMENT PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. 558140

    Patients

    Seq Age Sex Outcome Treatment
    1