BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - IMPLANT

    MDR report key: 12044303 · Received June 22, 2021

    Report

    Report Number
    1221934-2021-01957
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Date of Event
    May 1, 2021
    Report Date
    June 10, 2021
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION PROVIDED, THE FILE IS A REVIEW OF THE FOLLOWING JOURNAL ARTICLE: BUYUKKUSCU, M. O., ET AL (2020) THE INTERPOSITION OF SOFT TISSUE BETWEEN THE CORTICAL BUTTON AND FEMORAL LATERAL CORTEX SIGNIFICANTLY INCREASES BUTTON MIGRATION BUT DOES NOT NEGATIVELY AFFECT KNEE STABILITY AND CLINICAL OUTCOME. THE STUDY EMPHASIZES ON THE INVESTIGATION OF THE EFFECT OF SOFT TISSUE INTERPOSITION ON BUTTON MIGRATION AND CLINICAL OUTCOMES IN ANATOMICAL SINGLE-BUNDLE ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION. THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT FILE WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH A JOURNAL ARTICLE REVIEW. THE JOURNAL ARTICLE REVIEW INDICATED DEPUY MITEK PRODUCT FAILURE(S). MULTIPLE ATTEMPTS WERE DONE TO OBTAIN MORE INFORMATION FROM THE AUTHOR; HOWEVER, NO RESPONSE WAS RECEIVED. IT IS UNKNOWN IF COMPLAINTS DERIVED FROM THIS JOURNAL ARTICLE WERE PREVIOUSLY REPORTED AND DOCUMENTED IN THE DEPUY MITEK COMPLAINT SYSTEM AT THE TIME OF OCCURRENCE AS NO PRODUCT CODE/LOT NUMBER INFORMATION WAS PROVIDED TO PERFORM THE SEARCH. WITH THE INFORMATION PROVIDED, AND WITHOUT THE COMPLAINT DEVICE TO EVALUATE, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED PROBLEM. SINCE NO LOT NUMBER WAS PROVIDED, A MANUFACTURING RECORD EVALUATION OR STERILE LOAD REVIEW COULD NOT BE CONDUCTED. IF ANY ADDITIONAL INFORMATION IS OBTAINED, THIS COMPLAINT WILL BE RE-OPENED TO CAPTURE THAT INFORMATION. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN IMPLANT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER, 510-K NUMBER AND MANUFACTURING SITE NAME ARE UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    THIS FILE IS A REVIEW OF THE FOLLOWING JOURNAL ARTICLE: BUYUKKUSCU, M. O., ET AL (2020) THE INTERPOSITION OF SOFT TISSUE BETWEEN THE CORTICAL BUTTON AND FEMORAL LATERAL CORTEX SIGNIFICANTLY INCREASES BUTTON MIGRATION BUT DOES NOT NEGATIVELY AFFECT KNEE STABILITY AND CLINICAL OUTCOME. THE KNEE, VOL. 27, PAGES 891-898 (TURKEY). THE STUDY EMPHASIZES ON THE INVESTIGATION OF THE EFFECT OF SOFT TISSUE INTERPOSITION ON BUTTON MIGRATION AND CLINICAL OUTCOMES IN ANATOMICAL SINGLE-BUNDLE ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION. THE PATIENTS EVALUATED ON COURSE OF THIS STUDY: 84 PATIENTS. THE ARTICLE DESCRIBES THE FOLLOWING PROCEDURE: SINGLE-BUNDLE ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION. THE DEVICES INVOLVED WERE: UNKNOWN RIGIDLOOP IMPLANT. COMPLICATIONS DESCRIBED: BUTTON MIGRATION WAS OBSERVED IN 12 PATIENTS IN GROUP 1 AND TWO PATIENTS IN GROUP 2. HOWEVER, NO SIGNIFICANT DIFFERENCE WAS OBSERVED BETWEEN PATIENTS WITH AND WITHOUT TISSUE INTERPOSITION OR THOSE WITH AND WITHOUT BUTTON MIGRATION REGARDING KNEE STABILITY PARAMETERS AND CLINICAL OUTCOME. A COPY OF THIS LITERATURE ARTICLE IS ATTACHED TO THIS MEDWATCH REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940647 UNK - IMPLANT SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE MBI DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1