BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM XL 44-36 STD HMRL BRNG

    MDR report key: 16630098 · Received March 28, 2023

    Report

    Report Number
    0001825034-2023-00680
    Event Type
    Injury
    Date Received
    March 28, 2023
    Date of Event
    March 13, 2023
    Report Date
    November 2, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00880304475427
    PMA / PMN Number
    K193373
    Adverse Event
    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. D10: COMPR SRS PROX BDY - LG 42MM CAT: 211218 LOT: 990150. COMPR SRS MOD STEM - 6X75MM CAT: 211230 LOT: 778450. COMP RVRS SHLDR GLNSP STD 36MM CAT: 115310 LOT: 838930. COMP RVS TRAY CO 44MM CAT: 115370 LOT: 287200. COMP RVRS 25MM BSPLT HA+ADPTR CAT: 010000589 LOT: 177760. 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.

    Additional Manufacturer Narrative · 0

    (B)(4) MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-00659, 0001825034-2023-00661, 0001825034-2023-00664, 0001825034-2023-00678, 0001825034-2023-00679. CONCOMITANT MEDICAL PRODUCT(S): COMPR SRS PROX BDY - LG 42MM CAT: 211218 LOT: UNKNOWN; COMPR SRS MOD STEM - 6X75MM CAT: 211230 LOT: UNKNOWN; UNKNOWN GLENOSPHERE; UNKNOWN TRAY; UNKNOWN BASEPLATE. REPORT SOURCE, FOREIGN: UNITED KINGDOM. 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 REPORT WILL BE SUBMITTED. PRODUCT REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: - 6-MONTHS POST-OP: PATIENT REPORTS DIFFICULTY WITH ADL¿S, MODERATE PAIN, AND SEVERE TINGLING. NO SIGNIFICANT FINDINGS ON THE X-RAY. - 1-YEAR FOLLOW-OP: PATIENT REPORTS MODERATE DIFFICULTY WITH ADL¿S, SEVERE PAIN, AND MILD TINGLING. NO NEW ONSET OF NERVE PALSY. REACTIVE CALLUS ON SIDE OF PROSTHESIS NOTED ON THE X-RAY. - 3-YEAR FOLLOW-UP: MODERATE DIFFICULTIES WITH ADL¿S, AND MODERATE TINGLING AND PAIN. NO SIGNIFICANT FINDINGS ON THE X-RAY. - 5-YEAR FOLLOW-UP: SEVERE DIFFICULTIES WITH ADL¿S, AND SEVERE TINGLING AND PAIN. TREATMENT IS A SERIES OF SUPRASCAPULAR NERVE BLOCKS. REFERRED TO PHYSIO. NO RADIOGRAPHIC FINDINGS HAVE BEEN REPORTED. - ADMITTED AS A DAY CASE PATIENT FOR HER THIRD SERIES OF THREE RIGHT SIDED SUPRASCAPULAR NERVE BLOCKS. THE PROCEDURE WAS CARRIED OUT IN THE PAIN THEATRE UNDER ULTRASOUND CONTROL. IT WAS UNEVENTFUL AND THE PATIENT WAS DISCHARGED HOME SAFELY. OVERALL SHE HAS HAD A GOOD RESPONSE TO THE INJECTION. SHE WILL BE REVIEWED IN THE CLINIC IN FOUR MONTHS' TIME. THE REPORTED EVENT IS CONFIRMED AS THE MEDICAL RECORDS STATED THAT THE PATIENT EXPERIENCED PAIN AND NEUROVASCULAR DAMAGE. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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

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

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT IS EXPERIENCING SEVERE TINGLING AND PAIN IN RIGHT SHOULDER THAT INTERFERES WITH DAILY LIVING POST REVISION PROCEDURE. THE PATIENT HAS RECEIVED A SERIES OF SUPRASCAPULAR NERVE BLOCKS AND REFERRED TO PHYSIO, OUTCOME STILL PENDING. NO ADDITIONAL COMPLICATIONS HAVE BEEN REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    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
    3518 ARCOM XL 44-36 STD HMRL BRNG SHOULDER, PROSTHESIS KWS ZIMMER BIOMET, INC. XL-115363 998050 00880304475427
    578955 ARCOM XL 44-36 STD HMRL BRNG SHOULDER, PROSTHESIS KWS ZIMMER BIOMET, INC. XL-115363 998050 00880304475427

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Other