BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - IMPLANT

    MDR report key: 20515490 · Received October 23, 2024

    Report

    Report Number
    1221934-2024-03798
    Event Type
    Injury
    Date Received
    October 23, 2024
    Date of Event
    January 1, 2024
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MBI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY 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. 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. H11 ADDITIONAL NARRATIVE: G1, G4 (510K), H4: THIS REPORT IS FOR AN UNKNOWN IMPLANT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE EXPIRATION DATE, UDI NUMBER, MANUFACTURING SITE NAME, 510-K NUMBER AND DEVICE MANUFACTURE DATE 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. INVESTIGATION SUMMARY ==> THE COMPLAINT DEVICE WAS NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS, 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 A J&J MEDTECH ORTHOPAEDICS 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 J&J MEDTECH ORTHOPAEDICS COMPLAINT SYSTEM AT THE TIME OF OCCURRENCE AS NO PRODUCT CODE/LOT NUMBER INFORMATION WAS PROVIDED TO PERFORM THE SEARCH. GIVEN THAT NO LOT/SERIAL NUMBER WAS PROVIDED, A MANUFACTURING RECORD EVALUATION (MRE) REVIEW CANNOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE MRE REVIEW WILL BE PERFORMED. BASED ON THE CURRENT AVAILABLE INFORMATION, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. IF ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AND THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: PACHECO-GARCIA LM, MARTÍN-DOMÍNGUEZ LA, PERELLI S, MONLLAU JC, SIMÓN-SÁNCHEZ FJ, GUTIÉRREZ-DE LA O J, MESSA LAM, ESPREGUEIRA-MENDES J, MARTÍNEZ-GUAJARDO KV, MORALES-AVALOS R. COMBINATION OF THE MEDIAL PATELLOFEMORAL LIGAMENT RECONSTRUCTION WITH THE QUASI-ANATOMIC TECHNIQUE, TIBIAL TUBEROSITY OSTEOTOMY, LATERAL RETINACULUM RELEASE AND MOSAICPLASTY PRODUCES SATISFACTORY RESULTS FOR PATIENTS WITH PATELLO-FEMORAL INSTABILITY. 2-YEAR FOLLOW-UP. KNEE. 2024 SEP 4;51:44-57. DOI: 10.1016/J.KNEE.2024.08.011. EPUB AHEAD OF PRINT. PMID: 39236637. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS RETROSPECTIVE INVESTIGATION OF PROSPECTIVELY COLLECTED DATA STUDY IS TO EVALUATE THE FUNCTIONAL, RADIOLOGICAL, AND CLINICAL RESULTS OF THIS COMBINED APPROACH AND TO DEMONSTRATE THAT IT IS A SAFE PROCEDURE FOR PEOPLE WITH HIGH RIDING PATELLA, LATERAL RECURRENT PATELLAR INSTABILITY, SEVERE FOCAL CHONDRAL LESIONS IN THE PATELLA AND/OR FEMUR, AND AUGMENTED TT-TG DISTANCE. WE HYPOTHESIZED THIS SINGLE-STAGE APPROACH WOULD BE SAFE, IMPROVE PATELLAR INSTABILITY, DECREASE PAIN, AND IMPROVE KNEE FUNCTION WITH A LOW COMPLICATIONS RATE AND SHOW HIGH PATIENT SATISFACTION. BETWEEN AUGUST 2021 AND NOVEMBER 2021, A TOTAL OF 27 PATIENTS (6 MALE AND 21 FEMALE) WITH A MEAN AGE OF 28.6 YEARS ± 3.5 (RANGE 24¿33). MENISCAL PROCEDURES WERE PERFORMED IN 14 PATIENTS WITH MENISCAL SUTURING USING (TRUESPANTM MENISCAL REPAIR SYSTEM. DEPUY SYNTHES, J&J) IN 8 OF THOSE PATIENTS (6 MEDIAL AND 12 LATERAL) AND A PARTIAL MENISCECTOMY IN THE REMAINING 6 (5 MEDIAL AND 1 LATERAL). TO PERFORM THE LRR, THE KNEE WAS PLACED IN FULL EXTENSION, THE ACCESSORY SUPEROMEDIAL PORTAL WAS CREATED ABOUT 2.5 CM PROXIMAL TO THE SUPEROMEDIAL BORDER OF THE PATELLA, AND A LIMITED LRR WAS PERFORMED WITH A HOOK-TIP ELECTROCAUTERY DEVICE (MITEK, VAPR COOL PULSE 90, DEPUY SYNTHES, J&J) TO ASSIST WITH MEDIALIZATION DURING THE TUBERCLE TRANSFER. AFTER RELEASING THE GRACILIS TENDON (GT) FROM ITS TIBIAL ATTACHMENT, A NUMBER 2 HIGH-STRENGTH SUTURE (ORTHOCORD, DEPUY SYNTHES, J&J) WITH A KRACKOW MATTRESS WAS PLACED AT ITS DISTAL END. THE CARTILAGE LESION (PATELLAR AND/OR FEMORAL, DEPENDING ON THE AFFECTED STRUCTURE) AREA WAS PREPARED WITH A 6¿10 MM GUIDES OF DIAMETER AND 12¿15 MM DEPTH DEPENDING ON THE LESION AREA. LATER, THE OSTEOCHONDRAL GRAFTS WERE HARVESTED FROM THE NON-WEIGHTBEARING SURFACE OF THE SUPEROLATERAL TROCHLEAR PORTION (FIGURE 6) IN ALL PATIENTS WITH AN OSTEOCHONDRAL AUTO-GRAFT TRANSPLANT HARVESTER (CORTM PRECISION TARGETING SYSTEM, DEPUY, J&J). PATIENT SATISFACTION WAS ASSESSED SUBJECTIVELY AT THE 24-MONTH FOLLOW-UP. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES TRUESPAN MENISCAL REPAIR SYSTEM, VAPR COOL PULSE 90, ORTHOCORD AND COR PRECISION TARGETING SYSTEM. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - TRUESPAN MENISCAL REPAIR SYSTEM, UNK - VAPR COOL PULSE 90, UNK - ORTHOCORD AND UNK - COR PRECISION TARGETING SYSTEM. (QTY (B)(4) -1 POST-OP COMPLICATION THAT CONSISTED OF 1 PATIENT BEING RE-OPERATED (1-YEAR POST-OP) BECAUSE OF LOCAL IRRITATION CAUSED BY THE HARDWARE MATERIAL AT THE TTO SITE. A COPY OF THIS LITERATURE ARTICLE IS ATTACHED TO THIS MEDWATCH REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294623 UNK - IMPLANT SOFT-TISSUE ANCHOR, BIOABSORBABLE MBI DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention