BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULAR SURFACE (MC) LEFT 18 MM HEIGHT

    MDR report key: 19417659 · Received May 29, 2024

    Report

    Report Number
    3007963827-2024-00204
    Event Type
    Injury
    Date Received
    May 29, 2024
    Date of Event
    August 16, 2023
    Report Date
    May 29, 2024
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    MBH
    PMA / PMN Number
    K150090
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10- MEDICAL PRODUCT. FEMUR CEMENTED (CR) NARROW LEFT SIZE 7, ITEM# 42502006201, LOT# 65500337. ALL POLY PATELLA CEMENTED 32 MM DIAMETER, ITEM# 42540000032, LOT# 65927743. TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE D, ITEM# 42532006701, LOT# 65850492. PALACOS CEMENT, ITEM# 5081287, LOT# 9011100566. 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 THAT A PATIENT DEVELOPED PAIN, STIFFNESS, AND LIMITED RANGE OF MOTION AND UNDERWENT A MANIPULATION UNDER ANESTHESIA APPROXIMATELY TWO MONTHS POST IMPLANTATION DUE TO ARTHROFIBROSIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1826211 ARTICULAR SURFACE (MC) LEFT 18 MM HEIGHT PROSTHESIS, KNEE MBH ZIMMER ORTHOPAEDIC MFG. LTD. N/A 65484954

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R SEE H11