BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CR VIVACIT-E 36MM BRNG STD

    MDR report key: 17452920 · Received August 3, 2023

    Report

    Report Number
    0001822565-2023-02072
    Event Type
    Injury
    Date Received
    August 3, 2023
    Report Date
    November 15, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    K181611
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10: MEDICAL PRODUCTS: ITEM#: 110031399, MINI TRAY STD COCR +0 OFFSET; LOT#: 64505652. ITEM#: 010000589, COMP RVRS 25MM BSPLT HA+ADPTR; LOT#: 867350. ITEM#: 115396, COMP RVS CNTRL 6.5X30MM ST/RST; LOT#: 161620. ITEM#: 180550, COMP LK SCR 3.5HEX 4.75X15 ST; LOT#: 961090. ITEM#: 180553, COMP LK SCR 3.5HEX 4.75X30 ST; LOT#: 277490. ITEM#: 180553, COMP LK SCR 3.5HEX 4.75X30 ST; LOT#: 715000. ITEM#: 115310, COMP RVRS SHLDR GLNSP STD 36MM; LOT#: 260790. ITEM#: 180552, COMP LK SCR 3.5HEX 4.75X25 ST; LOT#: 279000. ITEM#: 113609, COMP PRIMARY STEM 9MM MICRO; LOT#: 559790. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED IN THE PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. DURING THE INVESTIGATION PROCESS A REVIEW OF THE STERILE CERTIFICATIONS WERE REVIEWED AND FOUND TO BE CONFORMING WITH NO APPLICABLE DEVIATIONS. DEVICES WERE VERIFIED TO HAVE GONE THROUGH ACCEPTABLE STERILIZATION PROCESS FOLLOWING ISO/AAMI/ASTM & EU PUBLISHED GUIDELINES. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE THE CONTROL OF ZIMMER BIOMET, SUCH AS EXTERNAL FACTORS, I.E. HOSPITAL/SURGICAL ENVIRONMENT, PROVIDER RELATED RISK FACTORS, AND/OR PATIENT COMORBIDITIES/RISK FACTORS. AS THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUES IDENTIFIED AFFECTING IMPLANT SAFETY OR EFFECTIVENESS, IMPLANTED PRODUCTS ARE NOT IDENTIFIED AS THE SOURCE OR CONTRIBUTING TO THE REPORTED INFECTION. 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT SHOULDER ARTHROPLASTY ON AND UNKNOWN DATE. THE PATIENT THEN UNDERWENT A REVISION SURGERY APPROXIMATELY FOUR (4) YEARS AGO FOR AN UNKNOWN REASON. SUBSEQUENTLY, THE PATIENT UNDERWENT THE FIRST STAGE OF A TWO-STAGE REVISION SURGERY ON AN UNKNOWN DATE DUE TO INFECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT HAS UNDERGONE THE FIRST STAGE OF A TWO-STAGE REVISION SURGERY WHERE A CEMENT SPACER WAS IMPLANTED FOR AN UNKNOWN REASON. THE PATIENT WILL UNDERGO THE SECOND STAGE REVISION SURGERY ON AN UNKNOWN DATE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. THERE HAS BEEN NO ADDITIONAL INFORMATION RECEIVED AT THIS TIME.

    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
    1801273 CR VIVACIT-E 36MM BRNG STD SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES PHX ZIMMER BIOMET, INC. 64354397
    284717 CR VIVACIT-E 36MM BRNG STD SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES PHX ZIMMER BIOMET, INC. 64354397

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other| H SEE H10 NARRATIVE.