BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LG HYBRID GLENOID BASE 4MM

    MDR report key: 7017437 · Received November 10, 2017

    Report

    Report Number
    0001825034-2017-10126
    Event Type
    Malfunction
    Date Received
    November 10, 2017
    Date of Event
    June 17, 2022
    Report Date
    November 10, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK060694
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. A2: YEAR OF BIRTH: 1968. D10: 118001 090990 VERSA-DIAL/COMP TI STD TAPER, 115740 239820 COMPR NANO HMRL PPS 40MM, 113956 155810 LG HYBRID GLENOID BASE 4MM, PT-113950 451180 PT HYBRID GLEN POST REGENEREX, 113053 622950 VERSA-DIAL 50X21X57 HUM HEAD. G2: FOREIGN COUNTRY: UNITED KINGDOM. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO THE LOCATION OF THE DEVICE IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REVIEW FROM A HEALTH CARE PROFESSIONAL: IT WAS REPORTED A PATIENT HAD A SHOULDER ARTHROPLASTY. SUBSEQUENTLY, FELL CAUSING A SHOULDER DISLOCATION AND UNDERWENT A MANIPULATION UNDER ANESTHESIA. APPROXIMATELY SEVEN MONTHS LATER, DEVELOPED SHOULDER PAIN, LEADING TO A SUBSCAPULARIS REPAIR WHICH WAS CONTRIBUTED FROM THE TRAUMA. THE UPPER EXTREMITIES ARE NOT USED FOR MOBILITY; THEREFORE, THE SHOULDER EXTREMITY WOULD NOT CAUSE OR CONTRIBUTE TO THE TRAUMATIC FALL THAT LED TO FURTHER INJURY. AS THE COMPLAINT INDICATES THE PATIENT SUSTAINED AN EXTERNAL TRAUMA THAT CAUSED THE COMPLICATIONS WITH NO ALLEGATIONS AGAINST THE DEVICE PRIOR TO THE EVENT, WOULD RECOMMEND NOT REPORTABLE. THIS FILE WILL BE CONSIDERED NOT REPORTABLE. 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

    IT WAS REPORTED THE PATIENT UNDERWENT A PRIMARY LEFT TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT FELL AND EXPERIENCE A DISLOCATION REQUIRING MANIPULATION TO RELOCATE APPROXIMATELY 4 MONTHS POST IMPLANTATION. THE PATIENT THEN UNDERWENT A SUBSCAPULARIS REPAIR DUE TO DAMAGE CAUSED BY THE FALL/DISLOCATION. THE PATIENT WAS THEN NOTED TO HAVE CONTINUED INSTABILITY AND THE ABILITY TO VOLUNTARILY DISLOCATE/SUBLUX THE SHOULDER AT THE 5-YEAR FOLLOW-UP. THE PATIENT WAS THEN REVISED APPROXIMATELY 8 YEARS POST IMPLANTATION DUE TO DISLOCATION AND SUBLUXATION. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE. AS NO ADDITIONAL INFORMATION OR PRODUCT IS AVAILABLE, WE ARE UNABLE TO PROVIDE FURTHER INFORMATION.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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

    THE CLINICAL PATIENT FELL ON AN UNKNOWN DATE CAUSING A DISLOCATION WHICH WAS MANIPULATED. THE PATIENT ALSO REPORTED UNUSUAL SHOULDER PAIN AND A SUBSCAPULARIS REPAIR OF THE LEFT SHOULDER WITH ANCHORS WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799759 LG HYBRID GLENOID BASE 4MM PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 155810

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Required Intervention| H SEE H10 NARRATIVE