BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERLOC POR LAT FMRL 12.5X145

    MDR report key: 12347811 · Received August 20, 2021

    Report

    Report Number
    0001825034-2021-02449
    Event Type
    Malfunction
    Date Received
    August 20, 2021
    Date of Event
    July 27, 2021
    Report Date
    October 18, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K830313
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT/PROVIDED PICTURES IDENTIFIED SCRATCHING ON THE NECK AND TAPER OF THE STEM. WATER MARKS\DISCOLORATION IS PRESENT ON THE DISTAL END OF THE STEM. ADDITIONALLY DIMENSIONAL ANALYSIS WAS PREFORMED, ANALYSIS FOUND THE OVERALL LENGTH OF THE STEM WAS MEASURED TO IDENTIFY THE SIZE. THE LENGTH FALLS WITHIN THE APPROPRIATE RANGE FOR A 12.5X145 STEM. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. REPORTED EVENT IS NOT RELATED TO A COMBINATION OF PRODUCTS; THEREFORE A COMPATIBILITY REVIEW IS NOT APPLICABLE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: PART: 11-363661, LOT: 829670, 36MM COCR MOD HD -3MM,, PART: 11-103205, LOT: 640430, TAPERLOC POR LAT FMRL 11X142, PART: 010000662, LOT: 6993850, G7 PPS LTD ACET SHELL 50D, PART: 20103604, LOT: 64952292, G7 LONGEVITY NEUTRAL 36MM D, PART: 98-B001-007-18, LOT: UNK, POR ST/G7 CP/XL LN/STD HD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STEM WOULD NOT SEAT PROPERLY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246676 TAPERLOC POR LAT FMRL 12.5X145 PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 425710

    Patients

    Seq Age Sex Outcome Treatment
    1