BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RAPIDLOC

    MDR report key: 9167521 · Received October 8, 2019

    Report

    Report Number
    1221934-2019-58850
    Event Type
    Injury
    Date Received
    October 8, 2019
    Report Date
    October 7, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN. (B)(4). 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: F. ALAN BARBER ET AL, 2006, "MENISCAL REPAIR WITH THE RAPIDLOC MENISCAL REPAIR DEVICE", ARTHROSCOPY: THE JOURNAL OF ARTHROSCOPIC AND RELATED SURGERY VOLUME 22 NUMBER 9 PAGES 962-966 , USA. THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE CLINICAL SUCCESS OF THE RAPIDLOC DEVICE. THE RAPIDLOC IS AN ALL-INSIDE, SELF-ADJUSTING, FLEXIBLE MENISCAL REPAIR DEVICE THAT COMBINES A SUTURE WITH AN ANCHOR COMPONENT AND, BY USING A REINFORCED SLIDING KNOT, ALLOWS FOR TIGHTENING TO COMPRESS AND HOLD THE REPAIRED MENISCAL SEGMENTS. THE PATIENTS EVALUATED ON COURSE OF THIS STUDY: A TOTAL OF 32 PATIENTS UNDERWENT 32 MENISCAL REPAIRS, WITH AN AVERAGE FOLLOW-UP OF 31 MONTHS (18 TO 48 MONTHS). IN ALL, 23 REPAIRS WERE DONE IN CONJUNCTION WITH ACL RECONSTRUCTION, AND 9 REPAIRS WERE CARRIED OUT IN STABLE KNEES. REPAIRS WERE MADE TO 25 MEDIAL MENISCI AND 7 LATERAL MENISCI. TEARS REPAIRED CONSISTED OF PERIPHERAL LONGITUDINAL TEARS WITH AN AVERAGE LENGTH OF 2 CM (RANGE, 15 TO 30 MM). THE ARTICLE DESCRIBES THE FOLLOWING PROCEDURE: EXCLUSION CRITERIA WERE PATIENTS WITH HORIZONTAL, TRANSVERSE, OR COMPLEX TEARS OF THE MENISCUS. THOSE WITH LONGITUDINAL TEARS WITH DEGENERATIVE CHANGES (WHICH ROLLED WHEN PROBED), MULTIPLE LONGITUDINAL MENISCUS TEARS, AND TEARS FOR WHICH ATTEMPTED REPAIR WAS UNSUCCESSFUL BECAUSE OF THE FRAGILE NATURE OF THE. TISSUE WERE EXCLUDED. THE MENISCAL REPAIR SURGICAL TECHNIQUE USED INVOLVED HEALING ENHANCEMENT BY RASPING AND TREPHINATION BUT NOT MARROW STIMULATION OR FIBRIN CLOT CREATION. THOSE UNDERGOING ACL RECONSTRUCTION USUALLY DID NOT NEED THEM CRUTCHES, WITHIN 1 TO 2 WEEKS AFTER SURGERY, AND THOSE WITH ISOLATED MENISCAL REPAIRS WERE USUALLY OFF CRUTCHES IN 1 TO 2 DAYS. PATIENTS COULD RETURN TO PIVOTING SPORTS ONCE INFLAMMATION HAD RESOLVED. FLEXION BEYOND 90° WAS DISCOURAGED FOR THE FIRST 4 WEEKS. THE SPECIFIC CRITERIA FOR A RETURN TO SPORTS WERE NO EFFUSION, FULL EXTENSION (COMPARABLE TO THE CONTRALATERAL KNEE), NEARLY FULL FLEXION (135°), AND GOOD STRENGTH. PATIENTS IN WHOM MENISCAL REPAIRS WERE DONE WITHOUT AN ASSOCIATED ACL RECONSTRUCTION WERE NOT TREATED LESS AGGRESSIVELY THAN PATIENTS WHO UNDERWENT ACL RECONSTRUCTION. THE DEVICES INVOLVED WERE: RAPIDLOC, A SUTURE MADE OF NO. 2 ETHIBOND AND NO. 2 PANACRYL. COMPLICATIONS MENTIONED IN THE CASE REPORT WERE: THE MOST COMMON ADVERSE EVENT WAS CUTTING OF THE SUTURE DURING RAPIDLOC INSERTION. ONE PATIENT HAD EXCORIATION AND GROOVING OF THE MEDIAL FEMORAL CONDYLE ASSOCIATED WITH FAILED REPAIR. ANOTHER PATIENT DEVELOPED A POSTOPERATIVE INFECTION. THE EARLY CLINICAL SUCCESS RATE WAS 87.5% WITH THE RAPIDLOC DEVICE. CHONDRAL GROOVING WAS OBSERVED IN A SINGLE CASE. OF 32 REPAIRS, 23 (72%) WERE DONE IN CONJUNCTION WITH ACL RECONSTRUCTION, AND 9 REPAIRS WERE CARRIED OUT IN STABLE KNEES. IN ALL, 25 MEDIAL MENISCI AND 7 LATERAL MENISCI WERE REPAIRED. ONE MEDIAL MENISCAL REPAIR WAS PERFORMED WITH THE USE OF A "HYBRID" TECHNIQUE. THIS HYBRID REPAIR, WHICH CONSISTED OF A COMBINATION OF 3 INSIDE-OUT NO. 2 BRAIDED POLYESTER SUTURES AND 3 RAPIDLOC DEVICES, WAS PERFORMED BECAUSE THE MEDIAL MENISCUS TEAR EXTENDED ANTERIORLY TO AN AREA THAT COULD NOT BE REACHED BY RAPIDLOC DEVICES. IN CONCLUSION, THE RAPIDLOC MENISCAL REPAIR DEVICE WAS FOUND TO HAVE A CLINICAL SUCCESS RATE OF 87.5%. CLINICAL MEASURES, INCLUDING TEGNER, LYSHOLM, CINCINNATI, AND EKDC, WERE ALL NOTED TO IMPROVE. EARLY DATA SUGGEST THAT THE RAPIDLOC IS AN EFFECTIVE ALL-INSIDE REPAIR DEVICE, BUT LONGER-TERM FOLLOW-UP IS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962827 UNKNOWN RAPIDLOC SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention