BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYBRID GLENOID IMPACTOR

    MDR report key: 8979286 · Received September 10, 2019

    Report

    Report Number
    0001825034-2019-03814
    Event Type
    Malfunction
    Date Received
    September 10, 2019
    Date of Event
    August 16, 2019
    Report Date
    December 3, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWA
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE GLENOID IMPACTOR IDENTIFIED THAT THE BLACK PLASTIC TIP FRACTURED IN HALF WITH INDENTATIONS SEEN ON THE OUTSIDE OF THE TIP. THE HANDLE SHOWS IMPACT MARKS ALONG WITH THE MARKS SEEN ON THE STRIKE PLATE. SOME SCUFFING CAN BE SEEN ON THE TIP NEAR THE THREADED PORTION. ON INSPECTION OF (021260) THERE IS A GAP SEEN BETWEEN THE BLACK PLASTIC TIP AND THE HANDLE. THREADS INSIDE THE TIP ARE STRIPPED. THE STRIKE PLATE HAS FRACTURED FROM THE HANDLE WITH IMPACT MARKS ON THE TOP SIDE AND SOME SCUFFING ON THE BOTTOM SIDE. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT 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.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORTING.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDRS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED: 0001825034-2019-03812, 0001825034-2019-03814. CONCOMITANT MEDICAL PRODUCTS: 110028879 IMPACTOR, LOT 760880, UDI: (B)(4). 406156 IMPACTOR, LOT 021260, UDI: (B)(4). 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 THE DEVICES FRACTURED DURING IMPACTION WITHOUT DELAY TO SURGERY OR ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773332 HYBRID GLENOID IMPACTOR IMPACTOR HWA ZIMMER BIOMET, INC. N/A 021260

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR