BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS 25MM BSPLT HA+ADPTR

    MDR report key: 11436796 · Received March 8, 2021

    Report

    Report Number
    0001825034-2021-00527
    Event Type
    Injury
    Date Received
    March 8, 2021
    Report Date
    March 24, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K193373
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D4: THE TAPER ADAPTER LOT NUMBER WAS TIED TO 2 LOTS FOR THE BASEPLATE. HOWEVER, IT IS UNKNOWN WHAT LOT# WAS UTILIZED FOR THIS PROCEDURE, BUT IS ONE OF THE FOLLOWING: ITEM#: 010000589, LOT#: 633710, MANUFACTURE DATE: MAR 27, 2020, STERILE EXPIRY DATE: MAR 27, 2030, UDI: (B)(4), 510K: K193373, FDA PROD CODE: KWS. ITEM#: 010000589, LOT#: 306180, MANUFACTURE DATE: MAR 27, 2020, STERILE EXPIRY DATE: MAR 27, 2030, UDI: (B)(4), 510K: K193373, FDA PROD CODE: KWS. REVIEW OF BOTH THE LOTS IDENTIFIED NO DEVIATIONS OR ANOMALIES. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. VISUAL EXAMINATION OF PICTURE IDENTIFIED TAPER ADAPTER ASSEMBLED WITH GLENOSPHERE. A DEFINITIVE ROOT CAUSE COULD NOT 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE RETURNED PRODUCTS IDENTIFIED THE FOLLOWING: THE BASEPLATE ADAPTOR WAS SCRATCHED AND BENT/WARPED/DAMAGED; THE COMPREHENSIVE REVERSE TRAY WAS WORN/DAMAGED WITH BIOLOGICAL DEBRIS; THE GLENOSPHERE HAD SCRATCHES; THE TAPER ADAPTOR WAS SCRATCHED AND WORN/DAMAGED WITH BIOLOGICAL DEBRIS; THE STANDARD HUMERAL BEARING WAS BROKEN/FRACTURED; AND THE SCREWS WERE WORN/BENT/DEFORMED. THE LOT ETCH FOR THE BASEPLATE ADAPTOR WAS NOT VISIBLE DUE TO WEAR. AS THE FRACTURED BEARING WAS NOT REPORTED BY THE CUSTOMER, THE FRACTURE MOST LIKELY OCCURRED DURING EXPLANTATION. THE ADDITIONAL INFORMATION DOES NOT CHANGE THE ROOT CAUSE OF THE PREVIOUS INVESTIGATION. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: CENTRAL SCREW - 115398 LOT: 355980; FIXED LOCKING SCREW- 180552 LOT: 265360; FIXED LOCKING SCREW - 180553 LOT: 699640; GLENOSPHERE 36+6MM - 115316 LOT: 171330; STANDARD HUMERAL TRAY - 115370 LOT: 452990; 36+3MM STD HUMERAL POLY XL-115364. FOREIGN: EVENT OCCURRED IN (B)(6). 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. PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT INITIAL PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO DISASSOCIATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334527 COMP RVRS 25MM BSPLT HA+ADPTR EXTREMITIES, IMPLANT KWS ZIMMER BIOMET, INC. N/A SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R