BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR CENTER POST REAMER

    MDR report key: 16232637 · Received January 24, 2023

    Report

    Report Number
    0001822565-2023-00200
    Event Type
    Malfunction
    Date Received
    January 24, 2023
    Date of Event
    January 3, 2023
    Report Date
    April 5, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00889024574779
    PMA / PMN Number
    K191814
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2023-00199 CONCOMITANT MEDICAL PRODUCTS: ITEM# SBGL3007; LOT# 64757906. ITEM# 118001; LOT# J7161209. ITEM# 113032; LOT# J7298794. ITEM# 113631; LOT# 65576468. ITEM# SAGL2042; LOT# 64975087. ITEM# SAGP0002; LOT# 65371619. ITEM# 405800; LOT# 65679619. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6: PROPOSED COMPONENT CODE - MECHANICAL (G04) - DRILL. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED WEAR AND TEAR THAT INDICATES REPEATED USE. APPROXIMATELY 50% OF THE TIP OF LOT 64768311 IS FRACTURED AND MISSING. THE REMAINING PORTION IS CRACKED. MEDICAL RECORDS WERE NOT PROVIDED. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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

    IT WAS REPORTED THAT THE REAMER BROKE AT THE TIP. NO PATIENT CONSEQUENCES HAVE BEEN REPORTED AS A RESULT OF THE EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    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
    997824 MODULAR CENTER POST REAMER PROSTHESIS, SHOULDER, NON-CONSTRAINED KWS ZIMMER BIOMET, INC. NI 64768311 00889024574779

    Patients

    Seq Age Sex Outcome Treatment
    1 Female