BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-36

    MDR report key: 12364405 · Received August 25, 2021

    Report

    Report Number
    0009613350-2021-00432
    Event Type
    Injury
    Date Received
    August 25, 2021
    Date of Event
    July 16, 2021
    Report Date
    October 7, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    KWT
    UDI-DI
    00889024483040
    PMA / PMN Number
    K052906
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. 1. EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED ON (B)(6) 2021.POST-SURGERY THERE WAS LOOSENING OF BASEPLATE INDICATED. SUBSEQUENTLY, UNDERWENT REVISION SURGERY ON (B)(6) 2021. HARM: S3 - INSTABILITY, MODERATE. HAZARDOUS SITUATION: IMPLANT DETERIORATES, BREAKS OR LOSES FUNCTION POSTOPERATIVELY. 2. REVIEW OF RECEIVED DATA: DUE DILIGENCE: NO FURTHER DUE DILIGENCE REQUIRED AS ALL REQUIRED INFORMATION TO SUPPORT THE CONCLUSION IS AVAILABLE OR WAS ALREADY REQUESTED. 3. PRODUCT EVALUATION: NO PRODUCT WAS RETURNED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED. 4. REVIEW OF PRODUCT DOCUMENTATION: DEVICE PURPOSE: ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. PRODUCT COMPATIBILITY: THE COMPATIBILITY CHECK WAS PERFORMED FROM WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. - DHR REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 5. CONCLUSION: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED ON (B)(6) 2021.POST-SURGERY THERE WAS LOOSENING OF BASEPLATE INDICATED. SUBSEQUENTLY, UNDERWENT REVISION SURGERY ON (B)(6) 2021. DUE TO SIGNIFICANT LACK OF INFORMATION A DETAILED INVESTIGATION COULD NOT BE PERFORMED, NEVERTHELESS BASED ON THE GIVEN INFORMATION THERE IS NO INDICATION OF A NON-CONFORMANCE OR COMPLAINT OUT OF BOX (COOB). BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER SWITZERLAND MANUFACTURING GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2021-00431-1.

    Description of Event or Problem · 0

    INVESTIGATION RESULTS ARE NOW AVAILABLE.

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCTS: ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-30; CATALOG#: 01.04223.030; LOT#: 3021340. BASE PLATE 15 MM POST LENGTH UNCEMENTED; CATALOG#: 00-4349-015-00; LOT#: 6468111. GLENOSPHERE 36 MM DIAMETER; CATALOG#: 00-4349-036-11; LOT#: 64844939. THERAPY DATE: (B)(6) 2021. THE MANUFACTURER DID NOT RECEIVE X-RAYS FOR REVIEW. OTHER DOCUMENTS WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND UNDERWENT REVISION SURGERY DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262586 ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-36 ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM KWT ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3046210 00889024483040

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R