BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMICAL SHOULDER DOMELOCK, HUMERAL HEAD, 44-16, R=24.4MM

    MDR report key: 17115123 · Received June 13, 2023

    Report

    Report Number
    0009613350-2023-00260
    Event Type
    Injury
    Date Received
    June 13, 2023
    Date of Event
    February 16, 2018
    Report Date
    August 9, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSD
    UDI-DI
    00889024480353
    PMA / PMN Number
    K193099
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. NO PRODUCTS WERE RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. DEVICES ARE USED FOR TREATMENT. SIX RADIOGRAPHIC IMAGES OF THE RIGHT SHOULDER WERE PROVIDED AND ASSESSED WITH THE FOLLOWING ASSESSMENT: RIGHT SHOULDER ARTHROPLASTY COMPONENTS ARE ANATOMICALLY ALIGNED. THERE IS NO ABNORMALITY. ALIGNMENT IS MAINTAINED WITH MINIMAL ANTERIOR POSITION OF THE HUMERAL HEAD IN RELATION TO THE GLENOID. ALIGNMENT IS MAINTAINED WITHOUT INTERVAL CHANGE. THE FOLLOWING IMPRESSIONS WERE ADDITIONALLY PROVIDED: ANATOMIC ALIGNMENT OF THE RIGHT SHOULDER ARTHROPLASTY WITH MINIMAL ANTERIOR POSITION OF THE HUMERAL HEAD IN RELATION TO THE GLENOID ON THE RADIOGRAPHS. THE HUMERAL HEAD IMPLANT DOES NOT APPEAR TOO LARGE (OVERSTUFFED). BONE QUALITY APPEARS MILDLY OSTEOPENIC ON ALL IMAGES. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350-2023-00258-1, 0009613350-2023-00259-1, 0009613350-2023-00261-1. 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

    (B)(4). D10: ITEM#: 01.04227.005; LOT#: 2885046; ITEM NAME: ANATOMICAL SHOULDER, ANATOMICAL SHOULDER DOMELOCK, DOME, CENTRIC. ITEM#: 01.04201.123; LOT#: 2894588; ITEM NAME: ANATOMICAL SHOULDER, HUMERAL STEM, UNCEMENTED, 12, 100 MM. ITEM#: 01.04214.340; LOT#: 2852772; ITEM NAME: ANATOMICAL SHOULDER, GLENOID, PEGGED, CEMENTED, S. G2-FOREIGN: SWITZERLAND. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350 -2023 -00258, 0009613350 -2023 -00259, 0009613350 -2023 -00261. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A CLINICAL STUDY THAT A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY APPROXIMATELY SIX (6) YEARS AGO. APPROXIMATELY SEVEN (7) MONTHS AFTER IMPLANTATION, THE PATIENT HAD DEVELOPED PAIN. ABOUT ONE AND HALF (1,5) YEARS LATER, INFECTION WAS RULED OUT AND COMPONENTS WERE FOUND TO BE STABLE, HOWEVER EXTENSIVE DEBRIDEMENT OF INTRA-AND EXTRA-ARTICULAR SCAR TISSUE WAS REQUIRED. THE HEAD WAS NOTED TO BE SLIGHTLY OVERSTUFFED AND SOMEWHAT SUBLUXATED VENTRALLY. AS OF THE FIVE (5) YEAR STUDY FOLLOW-UP VISIT, THE PATIENT IS SATISFIED AND ABLE TO COMPLETE THE MAJORITY OF DAILY ACTIVITIES WITH MINIMAL PAIN. THERE HAVE BEEN NO OTHER ADVERSE EVENTS OR COMPLICATIONS REPORTED. THE ORIGINAL STUDY COMPONENTS REMAIN IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A CLINICAL STUDY THAT A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY APPROXIMATELY SIX (6) YEARS AGO. APPROXIMATELY SEVEN (7) MONTHS AFTER IMPLANTATION, THE PATIENT HAD DEVELOPED PAIN. ABOUT ONE AND HALF (1,5) YEARS LATER, INFECTION WAS RULED OUT AND COMPONENTS WERE FOUND TO BE STABLE, HOWEVER EXTENSIVE DEBRIDEMENT OF INTRA-AND EXTRA-ARTICULAR SCAR TISSUE WAS REQUIRED. AS OF THE FIVE (5) YEAR STUDY FOLLOW-UP VISIT, THE PATIENT IS SATISFIED AND ABLE TO COMPLETE THE MAJORITY OF DAILY ACTIVITIES WITH MINIMAL PAIN. THERE HAVE BEEN NO OTHER ADVERSE EVENTS OR COMPLICATIONS REPORTED. THE ORIGINAL STUDY COMPONENTS REMAIN IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171327 ANATOMICAL SHOULDER DOMELOCK, HUMERAL HEAD, 44-16, R=24.4MM SHOULDER PROSTHESIS, REVERSE CONFIGURATION HSD ZIMMER SWITZERLAND MANUFACTURING GMBH 01.04212.445 2851157 00889024480353

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H SEE H10 NARRATIVE.