BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL 46X27X46 HUM HEAD

    MDR report key: 16270806 · Received January 31, 2023

    Report

    Report Number
    0001825034-2023-00169
    Event Type
    Injury
    Date Received
    January 31, 2023
    Date of Event
    December 27, 2022
    Report Date
    August 9, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    PMA / PMN Number
    K060716
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. ASSOCIATED PRODUCTS AND REPORTS: 0001825034-2023-00168. ITEM#PT-113950; LOT#960770. 0001825034-2023-00170. ITEM#118001; LOT#057540. 0001825034-2023-00172. ITEM#113952; LOT#539300. OTHER ASSOCIATED PRODUCTS: ITEM#113653; LOT#987670. ITEM#110008096; LOT#934310. ITEM#110005307; LOT#299460. ITEM#405669; LOT#127800 ITEM#110003484; LOT#336600. ITEM#110005306; LOT#614850.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D4: UDI - THIS IS A CLASS II IMPLANT THAT WAS MANUFACTURED PRIOR TO SEPTEMBER 24, 2015. THEREFORE, THIS DEVICE DID NOT HAVE A UDI AT THE TIME OF MANUFACTURE. H6: PROPOSED COMPONENT CODE - MECHANICAL (G04) - HEAD. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS AND RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: ABNORMAL ALIGNMENT (POSTERIOR SUBLUXATION) OF THE HUMERAL HEAD WITH RESPECT TO THE GLENOID. THERE IS SUGGESTION THAT THIS COULD BE PRESENT ON THE FRONTAL VIEW AS THERE IS POSSIBLE SLIGHTLY INCREASED SPACING OF THE GLENONHUMERAL JOINT WITHOUT OVERLAPPING OF THE HUMERUS WITH THE ACETABULUM; HOWEVER, THIS CAN ALSO BE TECHNICAL IN NATURE. OVERALL FIT AND BONE QUALITY LIKELY NORMAL WITH EXCEPTION OF PERIPROSTHETIC LUCENCY SURROUNDING THE GLENOID SCREW. THE SCREW MAY BE SLIGHTLY SUBLUXED DEEP TO THE ARTICULAR SURFACE OF THE GLENOID. NO INSTABILITY FOUND BESIDES THE ABNORMAL ALIGNMENT WHICH COULD CAUSE THE HARDWARE TO COME INTO CONTACT AND CAUSE NOISE. EVALUATION OF ROTATOR CUFF ARTHROPATHY AND ROTATOR CUFF TEAR CANNOT BE PERFORMED RADIOGRAPHICALLY; ONLY BY MRI OR CT ARTHROGRAM CAN THIS BE DONE. IN A SITUATION OF A MASSIVE FULL THICKNESS ROTATOR CUFF TEAR, THERE IS OFTEN LOSS OF THE SUBACROMIAL SPACE; HOWEVER, THIS IS NOT SEEN ON THIS RADIOGRAPH. ASSESSMENT FOR DEGENERATIVE JOINT DISEASE IS NOT AN ASSESSMENT TO BE MADE WITH AN ARTHROPLASTY, AS THE JOINT SPACE HAS BEEN REPLACED BY HARDWARE. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT UNDERWENT A LEFT SHOULDER REVISION APPROXIMATELY FOUR(4) YEARS POST IMPLANTATION DUE TO POSTERIOR INSTABILITY, PAIN AND NOISE. DURING THE REVISION THE LEFT SHOULDER WAS FOUND TO HAVE DEGENERATIVE JOINT DISEASE, ROTATOR CUFF ARTHROPATHY, AN IRREPARABLE ROTATOR CUFF TEAR, AND SUB LUXATION OF HUMERAL HEAD. ALL COMPONENTS, EXCEPT THE HUMERAL STEM, WERE REMOVED AND REPLACED WITH ZIMMER BIOMET PRODUCT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    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
    2105596 VERSA-DIAL 46X27X46 HUM HEAD PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED MBF ZIMMER BIOMET, INC. NI 572420

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H SEE NARRATIVE IN H10