BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVS CNTRL 6.5X35MM ST/RST

    MDR report key: 14218517 · Received April 27, 2022

    Report

    Report Number
    0001825034-2022-00888
    Event Type
    Injury
    Date Received
    April 27, 2022
    Report Date
    June 9, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00880304677098
    PMA / PMN Number
    K193373
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. 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. D2: DEVICE PRODUCT CODE ¿ PHX.. D4: PRODUCT ID FOR FIVE SCREWS WERE PROVIDED; HOWEVER, IT IS UNKNOWN WHICH SINGULAR SCREW OF THE FIVE HAD FRACTURED. THE PRODUCT INFORMATION FOR THE REMAINING FOUR SCREWS ARE AS FOLLOWS: ITEM #180555; LOT #568490. UDI: (B)(4). EXPIRATION DATE: DEC 7, 2030. ITEM #180554; LOT #182010 . UDI: (B)(4). EXPIRATION DATE: OCT 23, 2030. ITEM #180554; LOT #017910. UDI: (B)(4). EXPIRATION DATE: FEB 2, 2031. ITEM #180553; LOT #274460 . UDI: (B)(4). EXPIRATION DATE: MAR 3, 2031. D10: ITEM #110019066; LOT #196610. ITEM #110027734; LOT #196580. ITEM #110031378; LOT #196600. ITEM #00801102001; LOT #63504694. ITEM #110034355; LOT #936AAA2503. ITEM #110034355; LOT #924AAA2503. ITEM #115310; LOT #183440. ITEM #00435001313; LOT #63020932. ITEM #00434903600; LOT #64687459. H4: MANUFACTURER DATE: ITEM #180555; LOT #568490 - MANUFACTURING DATE: DEC 7, 2020. ITEM #180554; LOT #182010 - MANUFACTURING DATE: OCT 23, 2020. ITEM #180554; LOT #017910 - MANUFACTURING DATE: FEB 2, 2021. ITEM #180553; LOT #274460 - MANUFACTURING DATE: MAR 3, 2021. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: A4; B4; B5; G3; G6; H1; H2; H3; H6 NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: THERE IS A FRACTURED SCREW THAT APPEARS TO BE AT THE GLENOID IMPLANT OF A REVERSE-TYPE SHOULDER ARTHROPLASTY. IMPLANT FIT AND ALIGNMENT CANNOT BE DETERMINED ON THIS SINGLE VERY LIMITED IMAGE. BONE QUALITY CANNOT BE DETERMINED ON THIS IMAGE. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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 A PATIENT UNDERWENT A LEFT SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, HAD AN INCIDENT WHERE SHE PUT HER ARM IN A REACHING BACK POSITION AND FELT THE IMPLANT GIVE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT UNDERWENT A LEFT SHOULDER ARTHROPLASTY ONE (1) MONTH AGO. SUBSEQUENTLY, THE PATIENT HAD AN INCIDENT WHERE SHE PUT HER ARM IN A REACHING BACK POSITION AND FELT THE IMPLANT GIVE. IT WAS LATER CONFIRMED A SCREW FRACTURED. SURGEON PLANS TO REVISE BUT SURGERY IS NOT SCHEDULED YET. 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
    970124 COMP RVS CNTRL 6.5X35MM ST/RST SHOULDER PROSTHESIS, REVERSE CONFIGURATION KWS ZIMMER BIOMET, INC. NI 956940 00880304677098

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Other SEE NARRATIVE IN H10