BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD ANT STBLZD BRG 10X79

    MDR report key: 14840709 · Received June 28, 2022

    Report

    Report Number
    0001825034-2022-01504
    Event Type
    Injury
    Date Received
    June 28, 2022
    Date of Event
    March 22, 2022
    Report Date
    October 20, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304437159
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 183030 067970 VANGUARD CEMENTED CR FEMORALS, 141235 J7005617 BIOMET CC CRUCIATE TRAY 79MM. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 0001825034-2022-01503, 0001825034-2022-01505.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10: MEDICAL PRODUCT: BIOMET CC CRUCIATE TRAY 79MM: CATALOG#141235, LOT#J7005617; VANGUARD CR ILOK FEM-LT 67.5 67.5: CATALOG#183030, LOT#J7062867. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE UNRELATED TO THE IMPLANTED ZIMMER BIOMET DEVICE; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT PERFORMED. IT WAS REPORTED THAT A PATIENT EXPERIENCED SWELLING AND QUADRICEPS ATROPHY UP TO 4 MONTHS POST INITIAL TOTAL KNEE ARTHROPLASTY. AN ASPIRATION OF THE JOINT WAS PERFORMED. AN ASPIRATION IS A PUNCTURE PROCEDURE INTENDED TO WITHDRAWAL FLUID FROM THE JOINT AS A SPECIMEN FOR DIAGNOSTIC PURPOSES TO SUBMIT FOR LAB TESTING WHEN PAIN OR SWELLING ARE PRESENT. POSTOPERATIVE JOINT SWELLING IS A LOCALIZED SWELLING OR INFLAMMATION WHICH IS DESCRIBED AS AN ACCUMULATION OF FLUID IN THE INTERSTITIUM, THE SPACE BETWEEN CELLS, LOCATED BENEATH THE SKIN AND IN CAVITIES OF THE BODY. INFLAMMATION FROM SURGICAL TRAUMA CAUSES THE RELEASE OF MODERATORS CALLED CYTOKINES. SWELLING MAY INCREASE DURING ACTIVITIES OR WHEN SITTING OR STANDING IN ONE POSITION FOR AN EXTENDED PERIOD. SWELLING OR INFLAMMATION IS THE BODY¿S NATURAL RESPONSE TO HEAL DAMAGED TISSUE POSTOPERATIVELY. ACCORDING TO THE AAOS, MILD TO MODERATE SWELLING IS A NORMAL AND EXPECTED FINDING FOR THREE TO SIX MONTHS FOLLOWING SURGERY. ATROPHY IS A DECONDITIONING OF THE MUSCLES FROM LACK OF OR LIMITED USE. PHYSICAL THERAPY OR HOME EXERCISES ARE PRESCRIBED BEFORE AND AFTER A TOTAL JOINT PROCEDURE TO KEEP THE MUSCLES STRONG AND STABLE. RECOVERY FROM THE PHYSICAL DISRUPTION OF SURGERY IS DEPENDENT ON THE PATIENT'S COMORBIDITIES AND ABILITY TO WITHSTAND POSTOP THERAPY. ATROPHY CAN RESULT IN DIFFICULTY AMBULATING, IMBALANCE, AND WEAKNESS WHICH CAN FURTHER CONTRIBUTE TO SWELLING WITH LACK OF USE. ATROPHY CAN USUALLY BE REVERSED WITH STRETCHING, EXERCISES, AND INCREASED MOVEMENT. AS THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO POST-OPERATIVE SWELLING AND MUSCLE ATROPHY THAT ARE OUTSIDE THE CONTROL OF ZIMMER BIOMET, THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE NOT RELATED TO THE DEVICE. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT INITIAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED QUADRICEPS ATROPHY WITH SWELLING ON THE OPERATED KNEE, 4 MONTHS POST IMPLANTATION. THE PATIENT WAS TREATED WITH PUNCTURE. 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 AT TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY THE PATIENT DEVELOPED SWELLING AND QUADRICEP ATROPHY 4 MONTHS POST OP REQUIRING MEDICAL INTERVENTION WITH A PUNCTURE PROCEDURE. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2029549 VNGD ANT STBLZD BRG 10X79 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 067970 00880304437159

    Patients

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