BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP PRIMARY STEM 4MM MINI

    MDR report key: 10683717 · Received October 15, 2020

    Report

    Report Number
    0001825034-2020-03810
    Event Type
    Injury
    Date Received
    October 15, 2020
    Report Date
    December 8, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    UDI-DI
    00887868267710
    PMA / PMN Number
    K060692
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.  THE FOLLOWING SECTIONS WERE  UPDATED: B4, B5, G4, G7, H1, H2, H3, H6, H10. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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). CONCOMITANT MEDICAL PRODUCTS: ITEM# 115370; LOT# 716070. ITEM# 405800; LOT# 350470. ITEM# 115310; LOT# 365970. ITEM# 115399; LOT# 932800. ITEM# 180551; LOT# 118100. ITEM# 180554; LOT# 967250. ITEM# 180555; LOT# 869040. ITEM# 180556; LOT# 541880. ITEM# 180556; LOT# 723040. ITEM# PM555390; LOT# 207310. ITEM# PM700312; LOT# 192070. ITEM# PM700313; LOT# 192090. FOREIGN REPORT SOURCE: (B)(6). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT SHOULDER ARTHROPLASTY APPROXIMATELY THREE (3) YEARS AGO. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A REVISION DUE TO LOOSENING. SURGEON IS PLANNING ON JUST REVISING THE STEM TO A LONGER STEM. NO SURGERY HAS BEEN SCHEDULED TO DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1149363 COMP PRIMARY STEM 4MM MINI PROSTHESIS, EXTREMITIES MBF ZIMMER BIOMET, INC. NI 493740 00887868267710

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other SEE NARRATIVE IN H10