BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE SHOULDER SYSTEM NANO NUMERAL COMPONENT 30 MM

    MDR report key: 18954395 · Received March 21, 2024

    Report

    Report Number
    0001825034-2024-00795
    Event Type
    Injury
    Date Received
    March 21, 2024
    Date of Event
    February 26, 2024
    Report Date
    August 1, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSD
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). IT WAS FURTHER ASSESSED THAT THE PAIN WAS DUE TO ROTATOR CUFF TEAR, THEREFORE, THIS IS A NOT REPORTABLE EVENT AS THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE ROTATOR CUFF IS A GROUP OF MUSCLES AND TENDONS THAT SURROUND THE SHOULDER JOINT, KEEPING THE HEAD OF THE HUMERUS FIRMLY WITHIN THE SHALLOW SOCKET OF THE SHOULDER. ROTATOR CUFF INJURIES OCCUR MOST OFTEN IN PEOPLE WHO REPEATEDLY PERFORM OVERHEAD MOTIONS OR EXPERIENCE ANY SORT OF TRAUMA TO THE SHOULDER. DEGENERATIVE TEARS CAN ALSO OCCUR BECAUSE OF GRADUAL WEARING DOWN OF THE TENDON. THIS DEGENERATION NATURALLY OCCURS AS WE AGE. FACTORS THAT LEAD TO DEGENERATIVE TEARS INCLUDE REPETITIVE STRESS, LACK OF BLOOD SUPPLY, BONE SPURS, AND INCREASED AGE. COMMON SYMPTOMS OF A ROTATOR CUFF TEAR INCLUDE PAIN AT REST OR WITH ACTIVITY, WEAKNESS, AND CREPITUS. TYPICALLY, AN ANATOMIC SHOULDER IS PERFORMED WHEN THE ROTATOR CUFF IS STABLE AND INTACT, AND A REVERSE SHOULDER IS PERFORMED FOR AN INSUFFICIENT ROTATOR CUFF.

    Additional Manufacturer Narrative · 0

    (B)(4). A2:DOB 1953. G2: UK. G4 - THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN WARSAW, INDIANA MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K182516. D10 - MEDICAL PRODUCT: CATALOG #: 118001, VERSA-DIAL/COMP TI STD TAPER, LOT # 182780; CATALOG #: 113022, VERSA-DIAL 38X19X39 HUM HEAD, LOT # 395410; CATALOG #: 113952, SM HYBRID GLENOID BASE 4MM, LOT # 729090; CATALOG #: PT-113950, PT HYBRID GLEN POST REGENEREX, LOT # 849750; CATALOG #: UNKNOWN, UNKNOWN, LOT # UNKNOWN. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2024-00803, 0001825034-2024-00804, 0001825034-2024-00805, 0001825034-2024-00806.

    Description of Event or Problem · 0

    IT WAS FURTHER ASSESSED THAT THE PAIN WAS DUE TO ROTATOR CUFF TEAR, THEREFORE, THIS IS A NOT REPORTABLE EVENT AS THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INITIAL RIGHT SHOULDER ARTHROPLASTY APPROXIMATELY 9 YEARS AGO. SUBSEQUENTLY ABOUT A MONTH AGO THE PATIENT REPORTED UNUSUAL PAIN AND A DECREASE IN RANGE OF MOTION WITH REFERRAL FOR CONSULTANT AND UNKNOWN TREATMENT. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892921 COMPREHENSIVE SHOULDER SYSTEM NANO NUMERAL COMPONENT 30 MM EXTREMITIES IMPLANTS HSD ZIMMER BIOMET, INC. N/A 659640

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SEE H10.