BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAXIM FEMORAL

    MDR report key: 17341357 · Received July 18, 2023

    Report

    Report Number
    0001825034-2023-01671
    Event Type
    Injury
    Date Received
    July 18, 2023
    Date of Event
    April 21, 1998
    Report Date
    October 6, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. G2: AUSTRALIA. ADDITIONAL ASSOCIATED PRODUCTS & MDRS: UNK MAXIM BEARING UNK LOT; MDR: 0001825034-2023-01670. ADDITIONAL ASSOCIATED PRODUCTS: UNK MAXIM TIBIAL UNK LOT; UNK MAXIM PATELLA UNK LOT.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ARTHROFIBROSIS IS DEFINED AS THE DEVELOPMENT OF FIBROUS SCAR TISSUE WITHIN OR SURROUNDING A JOINT. ARTHROFIBROSIS IS A KNOWN POSTOPERATIVE PROCEDURE RELATED COMPLICATION THAT CAN OCCUR FROM SURGICAL IMPLANTATION OF NEW JOINT REPLACEMENT AS WELL AS FROM PREVIOUS INJURIES OR SURGICAL PROCEDURES. SCAR TISSUE FORMATION IS A NORMAL HEALING RESPONSE; HOWEVER, THE BUILDUP OF SUCH CAN RESULT IN PAIN, STIFFNESS, LIMITED RANGE OF MOTION, AND DIFFICULTY PROPERLY AMBULATING. IF EXCESS SCAR TISSUE DEVELOPS, CONSERVATIVE MEASURES SUCH AS EXERCISES OR PHYSICAL THERAPY WOULD BE ATTEMPTED FIRST. IF THESE ATTEMPTS FAIL, SURGICAL INTERVENTION SUCH AS MANIPULATION UNDER ANESTHESIA, ARTHROSCOPIC ARTHROLYSIS, OR OPEN ARTHROTOMY WOULD BECOME NECESSARY TO REMOVE THE FIBROUS TISSUE AND RESTORE JOINT FUNCTION. 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 A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, 3 YEARS POST IMPLANTATION, THE PATIENT EXPERIENCED STIFFNESS AND UNDERWENT AN ARTHROSCOPIC RELEASE AND SYNOVECTOMY. THE PATELLA AND TIBIA WERE FOUND GROSSLY STABLE AND THE KNEE WAS MANIPULATED TO 100* WITHOUT COMPLICATION. TWO DAYS LATER, THE PATIENT CONTINUED TO HAVE LOSS OF FLEXION AND UNDERWENT A MANIPULATION UNDER ANESTHESIA. THE KNEE WAS MANIPULATED TO 110* AND ALL IMPLANTS REMAIN IN PLACE.

    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
    169091 UNK MAXIM FEMORAL PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R