BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: LCP DISTAL FEMUR PLATE/SCREWS

    MDR report key: 18232166 · Received November 29, 2023

    Report

    Report Number
    8030965-2023-15012
    Event Type
    Injury
    Date Received
    November 29, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. D1, D2, D3, D4, G4-510K: THIS REPORT IS FOR AN UNKNOWN DISTAL FEMUR LOCKING COMPRESSION PLATE AND SCREWS/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. E1: INITIAL REPORTER ADDRESS : DEPARTMENT OF MEDICAL AND SURGICAL SPECIALTIES, RADIOLOGICAL SCIENCES, AND PUBLIC HEALTH. H3, H4, H6: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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.

    Description of Event or Problem · 0

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: ORANSKY, M. ET AL. (2022) ENDOSTEAL PLATING FOR THE TREATMENT OF MALUNIONS AND NONUNIONS OF DISTAL FEMUR FRACTURES, EUROPEAN JOURNAL OF ORTHOPAEDIC SURGERY & TRAUMATOLOGY, VOL. XX (XX), PAGES 1-9 ( ITALY). THE AIM OF THIS OBSERVATIONAL RETROSPECTIVE STUDY WAS TO DESCRIBE THE SURGICAL TECHNIQUE AND THE OUTCOME OF A CASE SERIES OF NONUNION AND MALUNION OF DISTAL FEMUR FRACTURES TREATED WITH AN ENDOSTEAL MEDIAL PLATE COMBINED WITH A LATERAL LOCKING PLATE AND WITH AUTOGENOUS BONE GRAFTING. BETWEEN (B)(6) 2011 AND (B)(6) 2019, A TOTAL OF 10 PATIENTS (7 MALE AND 3 FEMALE) WITH MEAN AGE OF 48.3 YEARS (RANGE 21¿67) WERE INCLUDED IN THE STUDY. THE INTRAMEDULLARY PLATE (4.5 MM TIBIAL DCP OR LOCKING COMPRESSION PLATE DE PUY SYNTHES) WAS ASSOCIATED ON THE LATERAL SIDE WITH A CONDYLAR BLADE-PLATE (CBP, DEPUY SYNTHES) IN 8 PATIENTS, WITH A LISS PLATE IN 1, AND WITH A LCP CONDYLAR PLATE 4.5/5.0 (LCP¿CP, DEPUY SYNTHES) IN ANOTHER. BONE GRAFT WAS OBTAINED USING RIA (REAMER-IRRIGATOR-ASPIRATOR; DE PUY SYNTHES) FROM THE CONTRALATERAL FEMUR IN 9 PATIENTS, WHILE PATIENT HAD BONE GRAFTING FROM POSTERIOR ILIAC CREST. THE MEAN FOLLOW-UP WAS 13.5 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 3 PATIENTS WERE NOT COMPLETELY CORRECTED IN PREOPERATIVE SHORTENING AND HAD RESIDUAL SHORTENING OF 1-2 CM: A 52 YEAR OLD MALE, A 21 YEAR OLD FEMALE AND A 65 YEAR OLD MALE PATIENTS. A 50 YEAR OLD MALE HAD UNSUCCESSFUL TREATMENT WITH THE C2 OPEN FRACTURE WHO ALSO HAD A CONCOMITANT COLON ADENOCARCINOMA WITH HEPATIC METASTASIS THAT DIED 12 MONTHS AFTER THE INITIAL TREATMENT. IN THIS CASE, THE BLADE PLATE FAILED AT SIX MONTHS AFTER SURGERY; ALSO HAD PULMONARY EMBOLISM. THIS REPORT IS FOR AN UNKNOWN SYNTHES DISTAL FEMUR LOCKING COMPRESSION PLATE AND SCREWS. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2137904 UNK - CONSTRUCTS: LCP DISTAL FEMUR PLATE/SCREWS PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention