BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY RESTORE PATCH

    MDR report key: 417109 · Received September 14, 2002

    Report

    Report Number
    MW1026183
    Event Type
    Injury
    Date Received
    September 14, 2002
    Date of Event
    June 12, 2002
    Report Date
    September 14, 2002
    Manufacturer
    *
    Product Code
    LMO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RIGHT SHOULDER SURGERY WAS PERFORMED TO TIE 2 TENDONS TOGETHER AND ADD A PIG/RESTORE PATCH WITH A GRAFT VS HOST REACTION PER DR. THE DR ADVISED PT THAT HE HAD CONTACTED THE FDA REGARDING THIS RESTORE PATCH WHEN PT ASKED IF HE HAD HEARD FROM THEM, HE HADN'T. ADVISED BY DR THAT THIS PROCEDURE HAD BEEN DONE 11 TIMES IN THE US AND HE HAD DONE 3 OF THEM. 3 MORE SURGERIES WERE NECESSARY INASMUCH AS THE RESTORE PATCH DISSOLVED IN THE RIGHT SHOULDER WHERE IT HAD BEEN REPLACED AND GOT INFECTED AND REQUIRED 6 DAYS ON THE HOSP, WHEN THE ORIGINAL SURGERY WAS DONE AS AN OUTPATIENT. ALSO NEEDED NURSES TWICE A DAY AT HOME FOR A MONTH TO SET UP IV VANCOMYCIN ANTIBIOTIC INJECTION AT A COST TO OF $110 PER DAY. STILL UNABLE TO RAISE ARM AFTER 3 MOS AND HAVING PHYSICAL THERAPY 3 TIMES A WEEK.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 11/27/02: A COPY OF THE CURRENT LABELING IS ATTACHED, AS REQUESTED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION, AS IT HAS RESORBED INTO THE SURROUNDING TISSUE. NO DESIGN CHANGES, POTENTIALLY RELATED TO THE EVENT, HAVE BEEN IMPLEMENTED SINCE THE DEVICE WAS FIRST MARKETED. NO STERILIZATION METHOD CHANGES HAVE BEEN IMPLEMENTED FOR THIS DEVICE. THE RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT IS A PORCINE-DERIVED DEVICE THAT IS INTENDED TO FUNCTION AS A RESORBABLE SCAFFOLD THAT IS GRADUALLY RESORBED AND REPLACED BY THE PT'S OWN SOFT TISSUE. THIS TYPICALLY TAKES PLACE OVER A 6-MONTH TIME PEROID FOLLOWING IMPLANTATION. NO PRODUCT FAILURES, IN THE TYPICAL SENSE (STRETCHING, TEARING, ETC) HAVE BEEN REPORTED TO DEPUY TO DATE. REPORTED EVENTS ARE TYPICALLY CASES OF PT REACTION THAT MAY HAVE BEEN RELATED TO THE ORTHOBIOLOGIC IMPLANT. THESE CASES HAVE BEEN DESCRIBED IN WORDS THAT IMPLY ALLERGIC REACTION TO THE PORCINE MATERIAL FROM WHICH THE IMPLANT IS PRODUCED. THE INSTRUCTIONS FOR USE FOR THIS DEVICE INCLUDES THE FOLLOWING STATEMENT, "THIS PRODUCT SHOULD NOT BE PLACED IN INDIVIDUALS WHO ARE ALLERGIC TO PORK OR PORK PRODUCTS OR WHO HAVE A HISTORY OF MULTIPLE SEVERE ALLERGIES, ALLERGIES TO ANIMAL PRODUCTS OR AN OVERLY SENSITIZED IMMUNE SYSTEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY RESTORE PATCH PIG PATCH LMO * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| S