BEUDAMED
    FDA Adverse Event Injury Summary report: N

    +2MM LATERAL OFFSET 25MM POST LENGTH BASE PLATE

    MDR report key: 17260141 · Received July 5, 2023

    Report

    Report Number
    0001822565-2023-01801
    Event Type
    Injury
    Date Received
    July 5, 2023
    Report Date
    November 2, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00889024269033
    PMA / PMN Number
    K130661
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 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). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10: ITEM#: 01.04223.042, INVERS/REVERS SCR SYST 4.5-42; LOT#: 2921547. ITEM#: 01.04223.036, INVERS/REVERS SCR SYST 4.5-36; LOT#: 2933860. ITEM#: 01.04223.042, INVERS/REVERS SCR SYST 4.5-42; LOT#: 2913746. ITEM#: 01.04223.036, INVERS/REVERS SCR SYST 4.5-36; LOT#: 2929678. 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. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT SHOULDER SURGERY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A REVISION SURGERY DUE TO AN UNKNOWN REASON.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT SHOULDER ARTHROPLASTY APPROXIMATELY FIVE AND A HALF YEARS AGO. THE PATIENT WAS THEN REVISED APPROXIMATELY FIVE MONTHS LATER FOR AN UNKNOWN REASON. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR ANOTHER REVISION SURGERY ON AND UNKNOWN DATE DUE TO THE IMPLANT LOOSENING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT SHOULDER ARTHROPLASTY APPROXIMATELY FIVE AND A HALF YEARS AGO. THE PATIENT WAS THEN REVISED APPROXIMATELY FIVE MONTHS LATER FOR AN UNKNOWN REASON. SUBSEQUENTLY, THE PATIENT IS EXPECTING TO UNDERGO A REVISION SURGERY DUE TO THE TM REVERSE BASEPLATE LOOSENING AND FALLING OUT OF PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232086 +2MM LATERAL OFFSET 25MM POST LENGTH BASE PLATE SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES PHX ZIMMER BIOMET, INC. 63652921 00889024269033
    418979 +2MM LATERAL OFFSET 25MM POST LENGTH BASE PLATE SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES PHX ZIMMER BIOMET, INC. 63652921 00889024269033

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other SEE H10 NARRATIVE.