BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN HIP FEMORAL STEM

    MDR report key: 19467125 · Received June 5, 2024

    Report

    Report Number
    1818910-2024-12296
    Event Type
    Death
    Date Received
    June 5, 2024
    Date of Event
    January 1, 2022
    Report Date
    June 5, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # ==> (B)(4) THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: DI MARTINO A, PEDERIVA D, BRUNELLO M, TASSINARI L, GERACI G, STEFANINI N, FALDINI C. OUTCOMES OF DIRECT ANTERIOR APPROACH FOR UNCEMENTED TOTAL HIP REPLACEMENT IN MEDIAL FEMORAL NECK FRACTURES: A RETROSPECTIVE COMPARATIVE STUDY ON THE FIRST 100 CONSECUTIVE PATIENTS. BMC MUSCULOSKELET DISORD. 2023 OCT 2;24(1):776. DOI: 10.1186/S12891-023-06919-4. PMID: 37784090; PMCID: PMC10544374. THERE IS LIMITED INFORMATION REGARDING THE PATIENT'S DEATH AT THIS TIME. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT/LOT NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT : THE DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: DI MARTINO A, PEDERIVA D, BRUNELLO M, TASSINARI L, GERACI G, STEFANINI N, FALDINI C. OUTCOMES OF DIRECT ANTERIOR APPROACH FOR UNCEMENTED TOTAL HIP REPLACEMENT IN MEDIAL FEMORAL NECK FRACTURES: A RETROSPECTIVE COMPARATIVE STUDY ON THE FIRST 100 CONSECUTIVE PATIENTS. BMC MUSCULOSKELET DISORD. 2023 OCT 2;24(1):776. DOI: 10.1186/S12891-023-06919-4. PMID: 37784090; PMCID: PMC10544374. OBJECTIVE/METHODS/STUDY DATA: THIS RETROSPECTIVE COHORT STUDY IDENTIFIED AND ANALYZED PATIENTS UNDERGOING DA THA FOR A FEMORAL NECK FRACTURE OVER A 4-YEAR PERIOD AT A LEVEL 1 ACADEMIC TRAUMA CENTER WHO WERE TREATED BY AN EXPERIENCED SENIOR SURGEON. 37 PATIENTS WERE INCLUDED WITHIN THE FINAL REVIEW. PATIENTS WERE IMPLANTED WITH UNK HIP ACETABULAR CUP PINNACLE, UNK HIP FEMORAL STEM TRI-LOCK OR UNK HIP FEMORAL STEM CORAIL, UNKNOWN HIP ACETABULAR LINERS, AND UNKNOWN HIP FEMORAL HEAD LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: UNK HIP ACETABULAR CUP PINNACLE, UNK HIP FEMORAL STEM TRI-LOCK OR UNK HIP FEMORAL STEM CORAIL, UNKNOWN HIP ACETABULAR LINER, AND UNKNOWN HIP FEMORAL HEAD. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN HIP FEMORAL STEM (QTY 2): ONE INTRAOPERATIVE GREATER TROCHANTER FRACTURE WAS TREATED WITH CERCLAGE CABLES. ONE PATIENT FELL ON POSTOPERATIVE DAY 7 AND DEHISCED THE SURGICAL INCISION. SHE WAS TREATED WITH AN IRRIGATION, DEBRIDEMENT, WOUND CLOSURE, AND POSTOPERATIVE ANTIBIOTICS. SHE WAS CONTINUED ON VANCOMYCIN FOR 1 MONTH BECAUSE OF AN INTRAOPERATIVE WOUND CULTURE WITH METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP ACETABULAR CUP PINNACLE (QTY 1): ONE PATIENT FELL ON POSTOPERATIVE DAY 7 AND DEHISCED THE SURGICAL INCISION. SHE WAS TREATED WITH AN IRRIGATION, DEBRIDEMENT, WOUND CLOSURE, AND POSTOPERATIVE ANTIBIOTICS. SHE WAS CONTINUED ON VANCOMYCIN FOR 1 MONTH BECAUSE OF AN INTRAOPERATIVE WOUND CULTURE WITH METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN HIP ACETABULAR LINER (QTY 1): ONE PATIENT FELL ON POSTOPERATIVE DAY 7 AND DEHISCED THE SURGICAL INCISION. SHE WAS TREATED WITH AN IRRIGATION, DEBRIDEMENT, WOUND CLOSURE, AND POSTOPERATIVE ANTIBIOTICS. SHE WAS CONTINUED ON VANCOMYCIN FOR 1 MONTH BECAUSE OF AN INTRAOPERATIVE WOUND CULTURE WITH METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN HIP FEMORAL HEAD (QTY 1): ONE PATIENT FELL ON POSTOPERATIVE DAY 7 AND DEHISCED THE SURGICAL INCISION. SHE WAS TREATED WITH AN IRRIGATION, DEBRIDEMENT, WOUND CLOSURE, AND POSTOPERATIVE ANTIBIOTICS. SHE WAS CONTINUED ON VANCOMYCIN FOR 1 MONTH BECAUSE OF AN INTRAOPERATIVE WOUND CULTURE WITH METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN HIP FEMORAL STEM (QTY 1): ONE PATIENT DIED 5 DAYS POST OP DUE TO CARDIAC ISCHEMIA. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP ACETABULAR CUP PINNACLE (QTY 1): ONE PATIENT DIED 5 DAYS POST OP DUE TO CARDIAC ISCHEMIA. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN HIP ACETABULAR LINER (QTY 1): ONE PATIENT DIED 5 DAYS POST OP DUE TO CARDIAC ISCHEMIA. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN HIP FEMORAL HEAD (QTY 1): ONE PATIENT DIED 5 DAYS POST OP DUE TO CARDIAC ISCHEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802889 UNKNOWN HIP FEMORAL STEM HIP FEMORAL STEM LPH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| R