BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLENOSPHERE FORCEPS

    MDR report key: 10934572 · Received December 2, 2020

    Report

    Report Number
    0001825034-2020-04244
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Date of Event
    November 12, 2020
    Report Date
    March 16, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HTD
    PMA / PMN Number
    K193373
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. A GLENOSPHERE FORCEPS WERE RETURNED FOR EVALUATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THE DEVICE TO BE FRACTURED. THE DEVICE HAS 10 YEARS OF FIELD SERVICE AGE AND SHOWS MULTIPLE SIGNS OF USAGE. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED NO METALLIC FOREIGN ITEMS. PATIENT SHOWS SIGNS OF MILD OSTEOPENIA. IF ANY FURTHER INFORMATION IS FOUND 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 AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT CODE -PHX. CONCOMITANT MEDICAL DEVICES: PART# 405883; LOT# 766920; PART# 405889; LOT# 632440; PART# 405800; LOT# 671610; PART# 115310; LOT# 294360; PART# 010000589; LOT# 661760; PART# 113628; LOT# 64411951; PART# 110031418; LOT# 64653405; PART# 110031399; LOT# 64841368; PART# 180552; LOT# 154390; PART# 180550; LOT# 700090; PART# 180550; LOT# 700090; PART# 180552; LOT# 096430; PART# 115395; LOT# 026820. 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. 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 · 1

    IT WAS REPORTED APPROXIMATELY TWO AND A HALF (2.5) WEEKS AGO, THE TIP OF THE INSTRUMENT WAS DISCOVERED TO BE BROKEN OFF. IT IS UNKNOWN WHEN THE FRACTURING OF THE DEVICE OCCURRED AND THE PROCEDURE WAS STILL COMPLETED WITH THE SAME DEVICE. THE REPORTER STATED THAT THE SURGEON DID NOT NOTE IN THE OP REPORT OR SEE IN THE IMAGES THAT THE PIECE WAS RETAINED BY THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1402276 GLENOSPHERE FORCEPS INSTRUMENT, EXTREMITIES HTD ZIMMER BIOMET, INC. NI 248080

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR