BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTICULAR SURFACE 12 MM HEIGHT

    MDR report key: 17073375 · Received June 6, 2023

    Report

    Report Number
    0001822565-2023-01524
    Event Type
    Malfunction
    Date Received
    June 6, 2023
    Date of Event
    May 17, 2023
    Report Date
    September 19, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00889024211254
    PMA / PMN Number
    K173057
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORT SOURCE BRAZIL. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED FLARED AND COMPRESSED LOCKING DOVETAIL FEATURES. MEDICAL RECORDS WERE NOT PROVIDED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO RELATED DEVIATIONS / ANOMALIES IDENTIFIED. DAMAGE TO THE ARTICULAR SURFACE CAN OCCUR IF THE ARTICULAR SURFACE IS NOT CORRECTLY PLACED AND ORIENTED BEFORE PUSHING IT USING THE INSERTER INSTRUMENT. DETAILED INSTRUCTIONS FOR INSERTING THE ARTICULAR SURFACE ARE PROVIDED IN LPS-FLEX FIXED BEARING KNEE SURGICAL TECHNIQUE (97-5964-102-00-REV0616) PG. 15-17. THE ROOT CAUSE IS ATTRIBUTED TO A FAILURE TO FOLLOW INSTRUCTIONS. COMPLAINT CONFIRMED BASED ON THE PRODUCT EVALUATION. IF ANY FURTHER INFORMATION IS RECEIVED 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

    IT WAS REPORTED THAT THE POLYETHYLENE IMPLANT DID NOT FIT INTO THE METALLIC TIBIAL BASE. SEVERAL ATTEMPTS WERE MADE WITH NO SUCCESS. ANOTHER ARTICULAR SURFACE WAS USED TO COMPLETE THE SURGERY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE, HOWEVER, NO MORE INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696397 ARTICULAR SURFACE 12 MM HEIGHT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 65467602 00889024211254

    Patients

    Seq Age Sex Outcome Treatment
    1 Female