BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC 133 T1 PPS HO 9X137MM

    MDR report key: 11471675 · Received March 12, 2021

    Report

    Report Number
    0001825034-2021-00662
    Event Type
    Malfunction
    Date Received
    March 12, 2021
    Date of Event
    February 16, 2021
    Report Date
    July 2, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K101086
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H1, H2, H3, H6, H10 COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. A TPRLC 133 T1 PPS HO 9X137MM, PART # 51-104090 FROM LOT 6892546, WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION FOUND THE POROUS COATING TO BE LIGHTLY MASHED. A SMALL AMOUNT OF FOREIGN DEBRIS IS PRESENT WITHIN THE POROUS COATING. DISCOLORATION WAS IDENTIFIED ON THE DISTAL PORTION OF THE STEM THAT APPEAR TO BE WATER SPOTS. THE OVERALL LENGTH AND COATING WIDTH WERE MEASURED VIA CALIPERS TO ASSIST IN IDENTIFYING THE PRODUCT. THE READINGS FALL WITHIN THE RANGES FOR A 9X137MM STEM. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED DEVIATIONS OR ANOMALIES DURING MANUFACTURING, THE DEVIATIONS OR ANOMALIES WOULD NOT HAVE ATTRIBUTED TO THE EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT DURING AN INITIAL PROCEDURE A SIZE 9 TAPERLOC STEM WAS IMPLANTED, IT STAYED PROUD 2CM. SURGEON EXTRACTED IT, REBROACHED WITH A SIZE 9 BROACH AND REATTEMPTED WITH SAME RESULT. SURGEON REBROACHED WITH A SIZE 10 AND ASKED FOR ANOTHER NEW SIZE 9 STEM. IT SOLVED THE ISSUE. THERE WAS A 15 MINUTE DELAY IN THE PROCEDURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373582 TPRLC 133 T1 PPS HO 9X137MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 6892546

    Patients

    Seq Age Sex Outcome Treatment
    1