BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE PT HYBRID GLEN POST REGENEREX

    MDR report key: 6900428 · Received September 28, 2017

    Report

    Report Number
    0001825034-2017-07498
    Event Type
    Injury
    Date Received
    September 28, 2017
    Date of Event
    August 31, 2009
    Report Date
    January 17, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK060694
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 113952, COMPREHENSIVE SM HYBRID GLENOID BASE 4MM, 014740, 113764, BIO MODULAR HUMERAL HEAD, 873150, 402433, COBALT-G HV BONE CEMENT 40GM B, 810350, 417200, OPTIVAC KIT 80GRAM DOUBLE MIX, 503902, 11-113706, BIO-MOD ST.10X115 W/ALIGN HOLE 936090. THE REPORTED EVENT IS CONFIRMED VIA OP NOTES. NO PRODUCTS WERE RETURNED; THEREFORE, THE VISUAL AND DIMENSIONAL INSPECTIONS WERE NOT PERFORMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. REVIEW OF THE OP NOTES IDENTIFIED THAT THERE WAS NO GROSS MOTION OF THE GLENOID COMPONENT NOTED. THE GLENOID WAS CUT INTO THREE OR FOUR PIECES AND THEN THE CEMENT ASSOCIATED WITH THE PEG HOLES WAS REMOVED. THE CENTRAL METALLIC REGENEREX PLUG WAS NOTED TO BE LOOSE AND CLEARLY WAS NOT BONE INGROWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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 · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 113952, COMPREHENSIVE SM HYBRID GLENOID BASE 4MM, 014740, 113764, BIO MODULAR HUMERAL HEAD, 873150, 402433, COBALT-G HV BONE CEMENT 40GM B, 810350, 417200, OPTIVAC KIT 80GRAM DOUBLE MIX, 503902. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-07499, 0001825034-2017-07500.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT PREVIOUSLY UNDERWENT A TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED AND CONVERTED TO A REVERSE TOTAL SHOULDER ARTHROPLASTY DUE TO PROGRESSIVE PAIN, POOR FUNCTION, INSTABILITY, ROTATOR CUFF DEFICIENCY, AND LOOSENING OF THE GLENOID POST. 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
    680480 COMPREHENSIVE PT HYBRID GLEN POST REGENEREX PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 327100

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R