BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP PRIMARY STEM 7MM MINI

    MDR report key: 8382201 · Received March 1, 2019

    Report

    Report Number
    0001825034-2019-00920
    Event Type
    Injury
    Date Received
    March 1, 2019
    Date of Event
    September 11, 2018
    Report Date
    June 24, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    PMA / PMN Number
    K060692
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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). MEDICAL PRODUCTS: PART # 115310 LOT # 990660 COMP RVRS SHLDR GLNSP STD 36MM; PART # 110005273 LOT # 184150 COMP CNV GLEN BASE NON HA; PART # XL-115363 LOT # 588250 OR 145510 ARCOM XL 44-36 STD HMRL BRNG; PART # 115375 LOT # 822460 OR 272100 COMP RVS TRAY CO 44MM ; PART # 115395 LOT # 650420 COMP RVS CNTRL 6.5X25MM ST/RST; PART # 180551 LOT # 969080 COMP LK SCR 3.5HEX 4.75X20 ST; PART # 180552 LOT # 715590 COMP LK SCR 3.5HEX 4.75X25 ST; PART # 405883 LOT # 538650 COMP RVS 3.2MM DRL ; PART # 405800 LOT # 905620 COMP. REV SHLDR 9 IN STEINMANN; PART # 405889 LOT # 538820 COMP RVS 2.7MM DIA DRL; PART # 110005237 LOT # 509950 COMP CONV GLEN LINER E1; PART # 118001 LOT # 120880 VERSA-DIAL/COMP TI STD TAPER. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 00921; 0001825034 - 2019 - 00922; 0001825034 - 2019 - 00923; 0001825034 - 2019 - 00924; 0001825034 - 2019 - 00925; 0001825034 - 2019 - 00926. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT PATIENT IS SUFFERING FROM CHRONIC PAIN AND NON FUNCTIONING JOINT (9) NINE MONTHS POST REVISION SURGERY. PATIENT IS UNDERGOING SEEKING CARE UNDER A PAIN MANAGEMENT SPECIALIST. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174643 COMP PRIMARY STEM 7MM MINI PROSTHESIS, SHOULDER MBF ZIMMER BIOMET, INC. N/A 292310

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention| S