BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTICULAR SURFACE FIXED BEARING (PS) RIGHT 10 MM HEIGHT

    MDR report key: 14353678 · Received May 11, 2022

    Report

    Report Number
    3007963827-2022-00131
    Event Type
    Malfunction
    Date Received
    May 11, 2022
    Date of Event
    April 13, 2022
    Report Date
    June 3, 2022
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    MBH
    UDI-DI
    00889024243514
    PMA / PMN Number
    K121771
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORT SOURCE: FOREIGN SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: D9; G3; H2; H3; H6 VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THE LOCKING FEATURE TO BE FLARED OUT AND A SECTION OF THE DOVETAIL FEATURE TO BE COMPRESSED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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 PERSONA- THE PERSONALIZED KNEE SURGICAL TECHNIQUE (97-5026-001-00, REV. 13) PG.44. THE ROOT CAUSE IS ATTRIBUTED TO USE ERROR. 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

    IT WAS REPORTED THAT DURING A KNEE PROCEDURE, THE TIBIAL INSERT WOULD NOT SEAT ON THE TIBIAL TRAY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1789470 ARTICULAR SURFACE FIXED BEARING (PS) RIGHT 10 MM HEIGHT PROSTHESIS, KNEE MBH ZIMMER ORTHOPAEDIC MFG. LTD. N/A 65135069 00889024243514

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown