BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP CONV GLEN LINER E1

    MDR report key: 11709668 · Received April 22, 2021

    Report

    Report Number
    0001825034-2021-00987
    Event Type
    Injury
    Date Received
    April 22, 2021
    Date of Event
    March 3, 2021
    Report Date
    July 26, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    K130390
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CORRECTED: D4 (INITIAL LOT NUMBER GIVEN WAS INCORRECT AS LOT IS UNKNOWN). D10: CAT#: 115310, LOT#: 861630, COMP RVRS SHLDR GLNSP STD 36MM. VISUAL INSPECTION OF THE RETURNED PRODUCT CONFIRMS IT HAS FRACTURED INTO MANY PIECES AND IT IS UNCLEAR IF ALL THE PIECES WERE RETURNED. SEM ANALYSIS CONCLUSION; EDGE LOADING ON THE ARTICULAR SURFACES IN RELATION TO EACH OTHER (POSSIBLY DUE TO LACK OF ADEQUATE SOFT TISSUE RETENTION) MAY HAVE RESULTED IN OVERLOADING FRACTURE. IT IS UNCLEAR WHAT SEQUENCE EVENTS OCCURRED IN EXACTLY WHAT ORDER REGARDING FRACTURED CENTRAL POST, FRACTURE OF THE 4 RETAINING PEG GEOMETRIES, AND MISMATCHED WEAR/DAMAGE OF THE TOP OF THE CENTRAL POST VS THE REST OF POLY BEARING AFTER METAL ON METAL ARTICULATION POSSIBLY OCCURRED. DHR REVIEW WAS NOT PERFORMED AS LOT NUMBER WAS NOT PROVIDED. 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 EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE PRODUCT CODE: PHX. CONCOMITANT MEDICAL PRODUCTS: CAT#: 110031399, LOT#: 64914569 , MINI TRAY STD COCR +0 OFFSET. CAT#: 110031418, LOT#: 64790162, CR PROLONG 36MM BRNG STD. CAT#:118001, LOT#: 022970, VERSA-DIAL/COMP TI STD TAPER. CAT#: 115310, LOT#: 661390, COMP RVRS SHLDR GLNSP STD 36MM. 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 THE PATIENT HAD A CONVERTIBLE GLENOID POLY PUT IN ON AN UNKNOWN DATE. SUBSEQUENTLY, THE CONVERTIBLE GLENOID POLY WAS BROKEN INTO SEVERAL PIECES CAUSING THE NEED FOR A REVISION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603385 COMP CONV GLEN LINER E1 PROSTHESIS, SHOULDER PHX ZIMMER BIOMET, INC. N/A 861630

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10.| SEE H10.