BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CMD 24-1157 PROMADE ELBOW

    MDR report key: 24763580 · Received April 2, 2026

    Report

    Report Number
    3008021110-2026-00165
    Event Type
    Injury
    Date Received
    April 2, 2026
    Date of Event
    February 2, 2026
    Report Date
    April 2, 2026
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    JDC
    UDI-DI
    08033390293051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXPLANTED COMPONENTS HAVE BEEN DISCARDED THEREFORE CANNOT BE RETURNED TO MANUFACTURER FOR ANALYSIS. REVIEW OF MANUFACTURING AND STERILIZATION RECORDS FOR INVOLVED COMPONENT HAS BEEN PERFORMED AND DID NOT HIGHLIGHT ANY ANOMALY OR NON-CONFORMITY RELEVANT TO THE ISSUE. THROUGH FOLLOW UP COMMUNICATION WITH COMPLAINT SOURCE IT WAS LEARNED THAT ISSUED WAS NOTICED BECAUSE PATIENT REPORTED DISLOCATION AND RE-TIGHTENING OF THE ORIGINAL SAFETY SCREW WAS PERFORMED BY SURGEON TO RE-ESTABLISH ELBOW FUNCTIONALITY. A NEW CUSTOM DEVICE (REFERENCE: (B)(4), SURGERY NOT YET PLANNED) WAS HOWEVER REQUESTED FOR FUTURE USE. NO CLINICAL HISTORY OR SPECIFIC PATIENT ACTIVITY THAT COULD HAVE CONTRIBUTED TO REPORTED ISSUE WAS SHARED, HOWEVER PRE-OP X-RAYS WERE PROVIDED TO BE ANALYSED. MEDICAL EXPERT REPORTED FOLLOWING CONSIDERATIONS FROM PATIENT X-RAYS: THE DISCONNECTION OF A CONUS IS HIGHLY INDICATIVE FOR A SURGICAL MISTAKE. IT IS EITHER NEVER SECURED IN THE FIRST PLACE CORRECTLY OR SOME MAJOR ROTATIONAL FORCE IS APPLIED WHICH AGAIN CAN ONLY BE DUE TO MISALIGNMENT, ROTATIONAL ERRORS OR SUCH. THE ENTIRE CONSTRUCT LOOKS BIG, USUALLY VERY SMALL AND SHORT IMPLANTS ARE USED IN THE FIRST PLACE, ESPECIALLY IN THE ULNA. THE RADIOGRAPHS OTHERWISE LOOK UNREMARKABLE IN TERMS OF THE IMPLANT AND THERE IS NO SIGN FOR IMPLANT RELATED FAILURE. THEREFORE, TAKING INTO ACCOUNT THAT: EXPLANTED COMPONENTS WON'T BE RETURNED. NO MANUFACTURING DEVIATION WERE IDENTIFIED THROUGH DHR REVIEW. MEDICAL EXPERT OPINION DOES NOT HIGHLIGHT ANY EVIDENCE OF IMPLANT RELATED FAILURE. THE MANUFACTURER HAS NO EVIDENCE TO CONSIDER THIS EVENT AS PRODUCT RELATED. THE EVENT REPORTED BY COMPLAINT SOURCE IS A REVISION OF A CUSTOM-MADE DEVICE. NO OCCURRENCE RATE CAN BE PROVIDED SINCE CUSTOMIZED IMPLANTS ARE MANUFACTURED AS SINGLE PIECES. BASED ON THE INVESTIGATION PERFORMED, NO CORRECTIVE ACTIONS IS REQUIRED FOR THIS SPECIFIC CASE. THE MANUFACTURER WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A COMBINED INITIAL-FINAL MDR.

    Description of Event or Problem · 0

    ON (B)(6), 2026, REVISION SURGERY WAS PERFORMED BECAUSE OF DISCONNECTION BETWEEN CUSTOM HUMERAL BODY AND CUSTOM HUMERAL STEM IN PROMADE TOTAL ELBOW CMD 24-1157. COMPLETE MEDICAL HISTORY OF THE PATIENT IS BELOW DETAILED. ON (B)(6) 2025, ORIGINAL PROSTHESIS WAS IMPLANTED, CONSISTING OF FOLLOWING COMPONENTS: TEMA ULNAR LINER (PN: 1560.50.021 LOT. 24AT3T6 STER. 2400221). TEMA ULNAR BODY (PN: 1552.14.021 LOT. 2228604 STER. 2300072). CUSTOM HUMERAL STEM (PN: 9617.25.31X LOT. 2433650 STER. 2400265). CUSTOM HUMERAL BODY (PN 9617.P9.00D LOT. 2433653 STER. 2400268). CUSTOM ULNAR STEM (PN: 9617.25.31Y LOT. 2436134 STER. 2400278). ON (B)(6) 2025, FIRST REVISION SURGERY (PREVIOUSLY REPORTED WITH MFR: 3008021110-2025-00021) WAS PERFORMED DUE TO DISLOCATION: IMPLANT DISSOCIATED AND WAS PRESSING ON THE HUMERAL SKIN. THEREFORE, THE SURGEON PERFORMED AN IMPLANT REDUCTION, WITHOUT REMOVING ANY COMPONENT, AND EXPECTING TO LINK WITH AXLE, WHEN AVAILABLE. ON (B)(6) 2025, DURING THE SECOND REVISION SURGERY (PREVIOUSLY REPORTED WITH MFR: 3008021110-2025-00051) THE SURGEON LINKED ORIGINAL PROMADE CUSTOM TOTAL ELBOW WITH AXLE #LARGE (PN: 1590.15.020, LOT: 2435933 - STER. 2500035). ON (B)(6) 2026, THIRD REVISION SURGERY (HEREBY REPORTED) WAS PERFORMED DUE TO A DISASSEMBLY BETWEEN THE ORIGINAL CUSTOM HUMERAL BODY AND STEM. SURGEON HAS SUCCESSFULLY EXTRACTED THE ORIGINAL AXLE TOO ACCESS THE SAFETY SCREW, RE-TIGHTENED THE HUMERAL BODY TO THE STEM WITH ALL SCREW IN PLACE AND IMPLANTED A NEW AXLE, RE-ESTABLISHING LINKED CONFIGURATION. SURGERY HAS BEEN COMPLETED AS INTENDED. EVENT OCCURRED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830570 CMD 24-1157 PROMADE ELBOW CMD 24-1157 HUMERAL BODY JDC LIMACORPORATE S.P.A. 9617.P9.00D 2433653 08033390293051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention