BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - IMPLANT

    MDR report key: 24800817 · Received April 7, 2026

    Report

    Report Number
    1221934-2026-01416
    Event Type
    Injury
    Date Received
    April 7, 2026
    Date of Event
    May 27, 2025
    Report Date
    April 7, 2026
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11: ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY==> THIS COMPLAINT FILE WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH A JOURNAL ARTICLE REVIEW. THE JOURNAL ARTICLE REVIEW INDICATED A DEPUY SYNTHES 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 SYNTHES 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 DEPUY SYNTHES 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11: ADDITIONAL NARRATIVE: B5: DURING SUBSEQUENT FOLLOW-UP WITH THE CUSTOMER ADDITIONAL INFORMATION WAS OBTAINED. THE REPORTER CLARIFIED THAT REGARDING THE PUBLISHED ARTICLE, ¿PHYSEAL SPARING TECHNIQUE REDUCES FEMORAL GROWTH DISTURBANCE IN PEDIATRIC ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PATIENTS.¿ ALTHOUGH A RIGIDLOOP DEVICE (MITEK SPORTS MEDICINE) WAS USED AS PART OF THE SURGICAL TECHNIQUE DESCRIBED IN THE STUDY, NO ADVERSE EVENTS, DEVICE MALFUNCTIONS, OR IMPLANT-RELATED FAILURES WERE IDENTIFIED OR REPORTED IN THE PATIENT COHORT. THERE ARE NO CASES OF ADVERSE EVENTS OR DEVICE MALFUNCTIONS AVAILABLE TO REPORT, AND THEREFORE NO ASSOCIATED PATIENT, CASE, OR LOT-SPECIFIC DATA. THE REPORTER CONFIRMED THAT NO IMPLANT-RELATED COMPLICATIONS ATTRIBUTABLE TO THE DEVICE WERE OBSERVED DURING THE STUDY PERIOD.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: NIELSEN TG, LARSEN JBS, NIELSEN MM, HELLFRITZSCH MB, FAUNØ PZ, LIND M. PHYSEAL SPARING TECHNIQUE REDUCES FEMORAL GROWTH DISTURBANCE IN PEDIATRIC ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PATIENTS. KNEE SURG SPORTS TRAUMATOL ARTHROSC. 2025 JUL 2. DOI: 10.1002/KSA.12763. EPUB AHEAD OF PRINT. PMID: 40601968. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS STUDY IS TO COMPARE THE DIFFERENCE IN LIMB LENGTH AND KNEE ANGLES BETWEEN TWO GROUPS OF PATIENTS WHO UNDERWENT ACL (ANTERIOR CRUCIATE LIGAMENT) RECONSTRUCTION AS CHILDREN USING A FEMORAL PHYSEAL SPARING TECHNIQUE AND A NON-PHYSEAL SPARING TECHNIQUE AT THE AUH. A TOTAL OF 113 PATIENTS WHO UNDERWENT ACL RECONSTRUCTION USING TWO DIFFERENT SURGICAL TECHNIQUES BETWEEN 2001¿2010 AND 2013¿2019, RESPECTIVELY. 33 IN N-PS (NON-PHYSEAL SPARING) WHO UNDERWENT ACL RECONSTRUCTION AND 80 IN PS (PHYSEAL SPARING) WHO UNDERWENT ACL RECONSTRUCTION USING RIGIDLOOP, DEPUY SYNTHES, WARSAW, USA. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: RIGIDLOOP, DEPUY SYNTHES, WARSAW, USA. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - IMPLANT (QTY 16) N=13 UNDERWENT ADDITIONAL ACL SURGERY (UNSPECIFIED INDICATION) N=1; SAGITTAL KNEE LAXITY - NO INTERVENTION REPORTED N=1; ROTATIONAL INSTABILITY - NO INTERVENTION REPORTED N=1; HAD A LIMB LENGTH DIFFERENCE OF >10MM - NO INTERVENTION REPORTED A COPY OF THIS LITERATURE ARTICLE IS ATTACHED TO THIS MEDWATCH REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859596 UNK - IMPLANT SOFT-TISSUE ANCHOR, BIOABSORBABLE HWC DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other