BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL2 TOTAL WRIST IMPLANT SYSTEM

    MDR report key: 13456013 · Received February 4, 2022

    Report

    Report Number
    1651501-2022-00005
    Event Type
    Injury
    Date Received
    February 4, 2022
    Report Date
    March 24, 2022
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    JWJ
    PMA / PMN Number
    K030037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    2 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 1651501-2022-00004. WRIGHTINGTON HOSPITAL (UPPER LIMB UNIT) (2022) PUBLISHED: PERIPROSTHETIC OSTEOLYSIS FOLLOWING A TOTAL WRIST REPLACEMENT ¿ A CASE SERIES OF 11 UNIVERSAL 2 IMPLANT (INTEGRA) AIM: ¿TO ANALYZE THE LOCATION AND NATURAL HISTORY OF PPO FOLLOWING A TOTAL WRIST REPLACEMENT AND TO DETERMINE WHETHER THIS WAS ASSOCIATED WITH EXCESSIVE POLYETHYLENE (PE) WEAR¿ METHOD: RETROSPECTIVE REVIEW OF ALL REVISION TWA IN THE LAST 7 YEARS: ELECTRONIC RECORDS: PRIMARY SURGERY: REVISION, RADIOGRAPHIC ASSESSMENT, OUTCOME MEASURES: EFFICACY (PROMS); SAFETY (COMPLICATIONS). RESULTS: TOTAL 10 PATIENTS (11 WRISTS); FEMALE (9), MALE (1). AGE RANGE; 43 TO 83 (AVG-67). REVISION AND POLY SIZE: MEAN TIME FROM PRIMARY TO REVISION; 7.8 YEARS (RANGE 5 TO 13). FOUR TWA SURVIVED <6YRS; 3 OUT OF 4 (75%) - SMALL POLY. PRE OP RADIOGRAPHS: 9 OUT OF 11 >2 MM RADIAL COMPONENT LOOSENING. REVISION: INTRAOPERATIVE FINDINGS (MALFUNCTIONS): CARPAL IMPLANT LOOSENING = 5 PTS. RADIAL IMPLANT LOOSENING = 3 PTS. PE WEAR IN 81% (9 OUT 11 WRISTS). COMPLICATIONS (ADVERSE EVENTS): FUSION NONUNION. WOUND INFECTION. 1 CARPAL TUNNEL SYMPTOMS. 1 PERSISTENT ULNAR SIDED PAIN- E/O PISIFORM. PNEUMOTHORAX. CONCLUSION: PERIPROSTHETIC OSTEOLYSIS LEADING CAUSE OF FAILURE? FLAW IN IMPLANT DESIGN. SMALL POLY SIZE - HIGHER RATE OF REVISION. POOR LONG-TERM SURVIVAL: TWA STILL A NOVEL PROCEDURE? PATIENT SELECTION / LOW DEMAND, RHEUMATOID PATIENT. MANY IMPLANTS OPTION; UNCERTAIN LONG-TERM EFFICACY AND SAFETY. ALTERNATIVE OPTIONS TO UNI 2; MOTEK/ RE-MOTION / WRIST FUSION. NEED FOR: LONGER TERM STUDIES / NATIONAL REGISTRY. THIS COMPLAINT IS FOR THE ADVERSE EVENTS.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1126415 UNIVERSAL2 TOTAL WRIST IMPLANT SYSTEM UNI2 TOTAL WRIST IMPLANT SYSTEM JWJ ASCENSION ORTHOPEDICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown