BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-42

    MDR report key: 13769460 · Received March 15, 2022

    Report

    Report Number
    0009613350-2022-00155
    Event Type
    Injury
    Date Received
    March 15, 2022
    Date of Event
    February 14, 2022
    Report Date
    July 25, 2022
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    KWS
    UDI-DI
    00889024483057
    PMA / PMN Number
    K052906
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: 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. DEVICES ARE USED FOR TREATMENT. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: THE HISTOPATHOLOGY REPORTED MILD PALE HISTIOCYTIC INFILTRATE, SUGGESTIVE OF PROSTHESIS WEAR; DEGENERATIVE CHANGES; NO EVIDENCE OF INFECTION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED FOR LOOSENING. IF ANY FURTHER INFORMATION IS FOUND 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

    CONCOMITANT MEDICAL PRODUCTS: ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-36: CATALOG#: 01.04223.036, LOT#: 3043248; BASE PLATE UNCEMENTED: CATALOG#: 00-4349-038-11, LOT#: 64556002; 40MM GLENOSPHERE: CATALOG#: 00-4349-040-11, LOT#: 64032723; 40MM +0MM OFFSET POLY LINER: CATALOG#: 00-4349-040-00, LOT#: 64560444. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE LOT NUMBER OF THE DEVICE WAS RECEIVED. THE DEVICE HISTORY RECORDS WILL BE REVIEWED DURING INVESTIGATION. 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). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2022-00154.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT REVISION OF TM REVERSE SHOULDER. GLENOID BASEPLATE HAD BECOME LOOSE. ONE GLENOID SCREW WAS FOUND TO HAVE BROKEN INTO TWO. THE PATIENT HAD AN INFECTED SKIN LESION TREATED 3 WEEKS PRIOR. BASEPLATE LOOSENING WAS DISCOVERED ONE WEEK AGO. SURGEON MENTIONED THAT INFECTED SKIN LESION AND THE FACT THE PATIENT IS A FARMER WITH HIGH PHYSICAL DEMANDS MAY HAVE CONTRIBUTED TO THE BASEPLATE LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696447 ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-42 ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM KWS ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3021386 00889024483057

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Hospitalization| R SEE H10 NARRATIVE