BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - IMPLANT

    MDR report key: 24236051 · Received February 2, 2026

    Report

    Report Number
    1221934-2026-00478
    Event Type
    Injury
    Date Received
    February 2, 2026
    Date of Event
    March 13, 2025
    Report Date
    February 2, 2026
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, CA
    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: D1, D4, G1, G4 (510K), H4: THIS REPORT IS FOR AN UNKNOWN IMPLANT DEVICE. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE EXPIRATION DATE, UDI NUMBER, 510-K NUMBER, MANUFACTURING SITE NAME, AND DEVICE MANUFACTURE DATE ARE UNKNOWN. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H6: 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.

    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: ACCORDING TO THE INFORMATION RECEIVED, IT WAS REPORTED THAT THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KARPYSHYN J, KIZAKI K, MA J, LICHT F, WONG I. BRIDGING RECONSTRUCTION FOR MASSIVE ROTATOR CUFF TEARS HAS A LOW RATE OF ARTHRITIC PROGRESSION AND MAINTAINED EXCELLENT CLINICAL OUTCOMES FOR A MINIMUM 5-YEAR FOLLOW-UP. J SHOULDER ELBOW SURG. 2025 NOV;34(11):2561-2570. DOI: 10.1016/J.JSE.2025.01.051. EPUB 2025 MAR 13. PMID: 40089011. OBJECTIVE/METHODS/STUDY DATA: THIS RETROSPECTIVE CHART REVIEW AIMS TO EVALUATE PROGRESSION OF ROTATOR CUFF ARTHROPATHY, GRAFT HEALING, AND CLINICAL OUTCOMES IN PATIENTS FOLLOWING BRR FOR LARGE TO MASSIVE ROTATOR CUFF TEARS WITH A MINIMUM 5-YEAR FOLLOW-UP. BETWEEN 2012 AND 2017, A TOTAL OF 45 PATIENTS WERE IDENTIFIED, OF WHICH, 9 (20%) WERE EXCLUDED, AS THEY UNDERWENT REOPERATION BEFORE THE 5-YEAR TIME POINT. THIS LEFT 36 PATIENTS FOR FINAL RADIOGRAPHIC ANALYSIS. THE PATIENTS UNDERWENT BRIDGING RECONSTRUCTION (BRR) USING HUMAN DERMAL ALLOGRAFT WHERE ELEVEN ORTHOCORD SUTURES (DEPUY SYNTHES, RAYNHAM, MA, USA) WERE PLACED THROUGH THE GRAFT AND TIED IN STICK KNOT CONFIGURATIONS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: ORTHOCORD SUTURES (DEPUY SYNTHES, RAYNHAM, MA, USA) ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - IMPLANT (QTY 8): N=5 PARTIAL GRAFT TEAR ¿ NO TREATMENT REPORTED. N=2 ROTATOR CUFF ARTHROPATHY PROGRESSION ¿ NO TREATMENT REPORTED. N=1 PROGRESSIVE ARTHRITIS ¿ REQUIRING REVERSE TOTAL SHOULDER ARTHROPLASTY. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - IMPLANT (QTY 1): N=1 PATIENT 1 HAD COMPLETE GRAFT TEAR WITH MILD SUPERIOR MIGRATION ¿ SUPERIOR CAPSULAR RECONSTRUCTION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - IMPLANT (QTY 1): N=1 PATIENT 2 HAD COMPLETE RETEAR ¿ REVISION BRIDGING RECONSTRUCTION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - IMPLANT (QTY 1): N=1 PATIENT 3 HAD PARTIAL GRAFT TEAR WITH WEAKNESS ¿ SUPERIOR CAPSULAR RECONSTRUCTION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - IMPLANT (QTY 1): N=1 PATIENT 4 HAD COMPLETE GRAFT TEAR WITH WEAK SHOULDER ¿ ROTATOR CUFF REPAIR. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - IMPLANT (QTY 1): N=1 PATIENT 5 HAD COMPLETE RETEAR ¿ SUPERIOR CAPSULAR RECONSTRUCTION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - IMPLANT (QTY 1): N=1 PATIENT 6 HAD COMPLETE RETEAR WITH SUBSCAPULARIS TEAR FROM SHOULDER DISLOCATION WHILE PLAYING HOCKEY ¿ ROTATOR CUFF REPAIR AND AUGMENT. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - IMPLANT (QTY 1): N=1 PATIENT 7 HAD PARTIAL GRAFT TEAR WITH SHOULDER PAIN AND WEAK SHOULDER ¿ SUPERIOR CAPSULAR RECONSTRUCTION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - IMPLANT (QTY 1): N=1 PATIENT 8 HAD PARTIAL GRAFT TEAR WITH SHOULDER PAIN AND WEAK SHOULDER ¿ REPAIR WITH SMALL INTERPOSITIONAL GRAFT. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - IMPLANT (QTY 1): N=1 PATIENT 9 HAD PARTIAL GRAFT TEAR WITH SHOULDER PAIN AND WEAK SHOULDER ¿ ROTATOR CUFF REPAIR AND AUGMENTION. THE COMPLAINT DEVICE WAS NOT RETURNED TO DEPUY SYNTHES, 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 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. 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KARPYSHYN J, KIZAKI K, MA J, LICHT F, WONG I. BRIDGING RECONSTRUCTION FOR MASSIVE ROTATOR CUFF TEARS HAS A LOW RATE OF ARTHRITIC PROGRESSION AND MAINTAINED EXCELLENT CLINICAL OUTCOMES FOR A MINIMUM 5-YEAR FOLLOW-UP. J SHOULDER ELBOW SURG. 2025 NOV;34(11):2561-2570. DOI: 10.1016/J.JSE.2025.01.051. EPUB 2025 MAR 13. PMID: 40089011. OBJECTIVE/METHODS/STUDY DATA: THIS RETROSPECTIVE CHART REVIEW AIMS TO EVALUATE PROGRESSION OF ROTATOR CUFF ARTHROPATHY, GRAFT HEALING, AND CLINICAL OUTCOMES IN PATIENTS FOLLOWING BRR FOR LARGE TO MASSIVE ROTATOR CUFF TEARS WITH A MINIMUM 5-YEAR FOLLOW-UP. BETWEEN 2012 AND 2017, A TOTAL OF 45 PATIENTS WERE IDENTIFIED, OF WHICH, 9 (20%) WERE EXCLUDED, AS THEY UNDERWENT REOPERATION BEFORE THE 5-YEAR TIME POINT. THIS LEFT 36 PATIENTS FOR FINAL RADIOGRAPHIC ANALYSIS. THE PATIENTS UNDERWENT BRIDGING RECONSTRUCTION (BRR) USING HUMAN DERMAL ALLOGRAFT WHERE ELEVEN ORTHOCORD SUTURES (DEPUY SYNTHES, RAYNHAM, MA, USA) WERE PLACED THROUGH THE GRAFT AND TIED IN STICK KNOT CONFIGURATIONS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: ORTHOCORD SUTURES (DEPUY SYNTHES, RAYNHAM, MA, USA) ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - IMPLANT (QTY 8): N=5 PARTIAL GRAFT TEAR ¿ NO TREATMENT REPORTED N=2 ROTATOR CUFF ARTHROPATHY PROGRESSION ¿ NO TREATMENT REPORTED N=1 PROGRESSIVE ARTHRITIS ¿ REQUIRING REVERSE TOTAL SHOULDER ARTHROPLASTY. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - IMPLANT (QTY 1): N=1 PATIENT 1 HAD COMPLETE GRAFT TEAR WITH MILD SUPERIOR MIGRATION ¿ SUPERIOR CAPSULAR RECONSTRUCTION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - IMPLANT (QTY 1): N=1 PATIENT 2 HAD COMPLETE RETEAR ¿ REVISION BRIDGING RECONSTRUCTION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - IMPLANT (QTY 1): N=1 PATIENT 3 HAD PARTIAL GRAFT TEAR WITH WEAKNESS ¿ SUPERIOR CAPSULAR RECONSTRUCTION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - IMPLANT (QTY 1): N=1 PATIENT 4 HAD COMPLETE GRAFT TEAR WITH WEAK SHOULDER ¿ ROTATOR CUFF REPAIR. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - IMPLANT (QTY 1): N=1 PATIENT 5 HAD COMPLETE RETEAR ¿ SUPERIOR CAPSULAR RECONSTRUCTION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - IMPLANT (QTY 1): N=1 PATIENT 6 HAD COMPLETE RETEAR WITH SUBSCAPULARIS TEAR FROM SHOULDER DISLOCATION WHILE PLAYING HOCKEY ¿ ROTATOR CUFF REPAIR AND AUGMENT. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - IMPLANT (QTY 1): N=1 PATIENT 7 HAD PARTIAL GRAFT TEAR WITH SHOULDER PAIN AND WEAK SHOULDER ¿ SUPERIOR CAPSULAR RECONSTRUCTION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - IMPLANT (QTY 1): N=1 PATIENT 8 HAD PARTIAL GRAFT TEAR WITH SHOULDER PAIN AND WEAK SHOULDER ¿ REPAIR WITH SMALL INTERPOSITIONAL GRAFT. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - IMPLANT (QTY 1): N=1 PATIENT 9 HAD PARTIAL GRAFT TEAR WITH SHOULDER PAIN AND WEAK SHOULDER ¿ ROTATOR CUFF REPAIR AND AUGMENTION. THIS EVENT OCCURRED AFTER A SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294038 UNK - IMPLANT UNK - IMPLANT MAI DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention