BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ARTICULAR SURFACE

    MDR report key: 13500497 · Received February 9, 2022

    Report

    Report Number
    0001822565-2022-00224
    Event Type
    Injury
    Date Received
    February 9, 2022
    Report Date
    February 9, 2022
    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
    FI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORT SOURCE: FOREIGN - (B)(6). LITERATURE - VON HINTZE, J., NIEMELÄINEN, M., SINTONEN, H., NIEMINEN, J., & ESKELINEN, A. (2021). OUTCOMES OF THE ROTATING HINGE KNEE IN REVISION TOTAL KNEE ARTHROPLASTY WITH A MEDIAN FOLLOW-UP OF 6.2 YEARS. BMC MUSCULOSKELETAL DISORDERS, 22(1), 336. HTTPS://DOI.ORG/10.1186/S12891-021-04205-9. ACCORDING TO TABERS MEDICAL DICTIONARY ¿ MANIPULATION OF A JOINT IS A MOBILIZATION TECHNIQUE, SOMETIMES INVOLVING A RAPID THRUST OR STRETCHING OF A JOINT, WITH OR WITHOUT ANESTHESIA. WITH ANESTHESIA IS (MUA). PER CLINICAL ORTHROPAEDICS AND RELATED RESEARCH (HOW TO TREAT THE STIFF TOTAL KNEE ARTHROPLASTY? A SYSTEMATIC REVIEW), MUA IS USED TO TREAT AND RESOLVE ARTHROFIBROSIS (SCAR TISSUE). THIS PROCEDURE IS PERFORMED TO INCREASE ARTICULAR MOTION AND REDUCE CHRONIC PAIN FROM ARTHROFIBROSIS. THE INDICATION FOR MANIPULATION UNDER ANESTHESIA IS RELATED TO LIMITED RANGE OF MOTION AND STIFFNESS DUE TO ADHESIONS/SCAR TISSUE. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2022-00223.

    Additional Manufacturer Narrative · 0

    (B)(4). REPORT SOURCE: FOREIGN - (B)(6). LITERATURE - VON HINTZE, J., NIEMELÄINEN, M., SINTONEN, H., NIEMINEN, J., & ESKELINEN, A. (2021). OUTCOMES OF THE ROTATING HINGE KNEE IN REVISION TOTAL KNEE ARTHROPLASTY WITH A MEDIAN FOLLOW-UP OF 6.2 YEARS. BMC MUSCULOSKELETAL DISORDERS, 22(1), 336. HTTPS://DOI.ORG/10.1186/S12891-021-04205-9. ACCORDING TO TABERS MEDICAL DICTIONARY ¿ MANIPULATION OF A JOINT IS A MOBILIZATION TECHNIQUE, SOMETIMES INVOLVING A RAPID THRUST OR STRETCHING OF A JOINT, WITH OR WITHOUT ANESTHESIA. WITH ANESTHESIA IS (MUA). PER CLINICAL ORTHOPAEDICS AND RELATED RESEARCH (HOW TO TREAT THE STIFF TOTAL KNEE ARTHROPLASTY? A SYSTEMATIC REVIEW), MUA IS USED TO TREAT AND RESOLVE ARTHROFIBROSIS (SCAR TISSUE). THIS PROCEDURE IS PERFORMED TO INCREASE ARTICULAR MOTION AND REDUCE CHRONIC PAIN FROM ARTHROFIBROSIS. THE INDICATION FOR MANIPULATION UNDER ANESTHESIA IS RELATED TO LIMITED RANGE OF MOTION AND STIFFNESS DUE TO ADHESIONS/SCAR TISSUE. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2022-00223.

    Description of Event or Problem · 0

    A JOURNAL ARTICLE WAS RETRIEVED FROM BMC MUSCULOSKELETAL DISORDERS (2021) THAT REPORTED A STUDY FROM FINLAND THAT LOOKED AT SURVIVAL RATE AND OUTCOMES IN REVISION ROTATING HINGE KNEE (RHK) ARTHROPLASTIES. THE STUDY REPORTED ONE PATIENT EXPERIENCED STIFFNESS THREE DAYS POSTOP AND WAS SUBSEQUENTLY TREATED WITH A MANIPULATION UNDER ANESTHESIA. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    A JOURNAL ARTICLE WAS RETRIEVED FROM BMC MUSCULOSKELETAL DISORDERS (2021) THAT REPORTED A STUDY FROM FINLAND THAT LOOKED AT SURVIVAL RATE AND OUTCOMES IN REVISION ROTATING HINGE KNEE (RHK) ARTHROPLASTIES. THE STUDY REPORTED ONE PATIENT EXPERIENCED STIFFNESS THREE DAYS POSTOP AND WAS SUBSEQUENTLY TREATED WITH A MANIPULATION UNDER ANESTHESIA. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327207 UNKNOWN ARTICULAR SURFACE PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R