BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN HIP FEMORAL HEAD

    MDR report key: 19333700 · Received May 16, 2024

    Report

    Report Number
    1818910-2024-10835
    Event Type
    Death
    Date Received
    May 16, 2024
    Date of Event
    December 1, 2023
    Report Date
    May 16, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). D4: THE DEVICE CATALOG NUMBER IS UNKNOWN; THEREFORE, UDI IS UNAVAILABLE. 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. THE SOURCE OF THE INFORMATION IS (REPORT SOURCE). 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THIS COMPLAINT WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH A JOURNAL ARTICLE REVIEW. FOLLOW-UPS WERE DONE TO TRY AND OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR OF THE JOURNAL ARTICLE. NO FURTHER INFORMATION WAS RECEIVED. 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED. FERNÁNDEZ-PALOMO J, GONZÁLEZ-POLA R. COMPARISON OF EARLY COMPLICATIONS FOR PRIMARY TOTAL HIP ARTHROPLASTY USING MODIFIED DIRECT ANTERIOR APPROACH AND LATERAL APPROACH. CIR CIR. 2023;91(5):587-595. ENGLISH. DOI: 10.24875/CIRU.22000402. PMID: 37844887. THE GOAL OF THE STUDY WAS TO ASSESS THE PROGRESSION OF 150 TOTAL HIP ARTHROPLASTY PROCEDURES IN THE FIRST 90 POSTOPERATIVE DAYS. 75 PATIENTS UNDERWENT A MODIFIED DIRECT ANTERIOR APPROACH (MDAA) USING A MINIMALLY INVASIVE TECHNIQUE WITH A SPECIAL TABLE, AND 75 PATIENTS UNDERWENT A DIRECT LATERAL APPROACH (DLA). MDAA PATIENTS WERE IMPLANTED WITH COMPETITOR PRODUCTS. DLA PATIENTS WERE IMPLANTED WITH SUMMIT STEM, PINNACLE CUP, POLYETHYLENE LINER, AND CERAMIC OR METAL FEMORAL HEAD. ADVERSE EVENT(S) POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL STEM SUMMIT (QTY 1) 1 PATIENT WITH A REPORTED DEATH WITHIN 48 HOURS DUE TO CARDIAC PROBLEMS. ADVERSE EVENT(S) POSSIBLY ASSOCIATED WITH UNK HIP ACETABULAR CUP PINNACLE (QTY 1) 1 PATIENT WITH A REPORTED DEATH WITHIN 48 HOURS DUE TO CARDIAC PROBLEMS. ADVERSE EVENT(S) POSSIBLY ASSOCIATED WITH UNK HIP ACETABULAR LINER POLY (QTY 1) 1 PATIENT WITH A REPORTED DEATH WITHIN 48 HOURS DUE TO CARDIAC PROBLEMS. ADVERSE EVENT(S) POSSIBLY ASSOCIATED WITH UNKNOWN HIP FEMORAL HEAD (QTY 1) 1 PATIENT WITH A REPORTED DEATH WITHIN 48 HOURS DUE TO CARDIAC PROBLEMS. ADVERSE EVENT(S) POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL STEM SUMMIT (QTY 47) 6 PATIENTS WITH INTRA-OP CALCAR/TROCHANTERIC FRACTURES. ONE PATIENT WAS TREATED WITH ADDITIONAL DEVICES (FIGURE 6). THERE WAS NO MENTION OF INTERVENTION FOR THE REMAINING 5 FRACTURES. 14 PATIENTS WITH MOTOR NEUROLOGICAL LESIONS. NO TREATMENT INDICATED. 1 PATIENT WITH PULMONARY EMBOLISM. NO TREATMENT INDICATED. 1 PATIENT WITH FAT EMBOLISM. NO TREATMENT INDICATED. 15 PATIENTS WITH WOUND INFECTION/LESION. ONE PATIENT WAS TREATED WITH AN ADDITIONAL SURGICAL INTERVENTION (FIGURE 5). THERE WAS NO MENTION OF INTERVENTION FOR THE REMAINING 14 PATIENTS. 2 PATIENTS WITH HEMATOMA. NO TREATMENT INDICATED. 5 PATIENTS WITH LEG LENGTH DISCREPANCY. NO TREATMENT INDICATED. 1 PATIENT WITH HETEROTOPIC OSSIFICATION. NO TREATMENT INDICATED. 2 PATIENTS WITH DVT. NO TREATMENT INDICATED. ADVERSE EVENT(S) POSSIBLY ASSOCIATED WITH UNK HIP ACETABULAR CUP PINNACLE (QTY 44) 3 PATIENTS WITH INTRA-OP ACETABULAR FRACTURES. ALL TREATED WITH BONE GRAFT. 14 PATIENTS WITH MOTOR NEUROLOGICAL LESIONS. NO TREATMENT INDICATED. 1 PATIENT WITH PULMONARY EMBOLISM. NO TREATMENT INDICATED. 1 PATIENT WITH FAT EMBOLISM. NO TREATMENT INDICATED. 15 PATIENTS WITH WOUND INFECTION/LESION. ONE PATIENT WAS TREATED WITH AN ADDITIONAL SURGICAL INTERVENTION (FIGURE 5). THERE WAS NO MENTION OF INTERVENTION FOR THE REMAINING 14 PATIENTS. 2 PATIENTS WITH HEMATOMA. NO TREATMENT INDICATED. 5 PATIENTS WITH LEG LENGTH DISCREPANCY. NO TREATMENT INDICATED. 1 PATIENT WITH HETEROTOPIC OSSIFICATION. NO TREATMENT INDICATED. 2 PATIENTS WITH DVT. NO TREATMENT INDICATED. ADVERSE EVENT(S) POSSIBLY ASSOCIATED WITH UNK HIP ACETABULAR LINER POLY (QTY 42) 14 PATIENTS WITH MOTOR NEUROLOGICAL LESIONS. NO TREATMENT INDICATED. 1 PATIENT WITH PULMONARY EMBOLISM. NO TREATMENT INDICATED. 1 PATIENT WITH FAT EMBOLISM. NO TREATMENT INDICATED. 1 PATIENT WITH DISLOCATION. NO TREATMENT INDICATED. 15 PATIENTS WITH WOUND INFECTION/LESION. ONE PATIENT WAS TREATED WITH AN ADDITIONAL SURGICAL INTERVENTION (FIGURE 5). THERE WAS NO MENTION OF INTERVENTION FOR THE REMAINING 14 PATIENTS. 2 PATIENTS WITH HEMATOMA. NO TREATMENT INDICATED. 5 PATIENTS WITH LEG LENGTH DISCREPANCY. NO TREATMENT INDICATED. 1 PATIENT WITH HETEROTOPIC OSSIFICATION. NO TREATMENT INDICATED. 2 PATIENTS WITH DVT. NO TREATMENT INDICATED. ADVERSE EVENT(S) POSSIBLY ASSOCIATED WITH UNKNOWN HIP FEMORAL HEAD (QTY 42) 14 PATIENTS WITH MOTOR NEUROLOGICAL LESIONS. NO TREATMENT INDICATED. 1 PATIENT WITH PULMONARY EMBOLISM. NO TREATMENT INDICATED. 1 PATIENT WITH FAT EMBOLISM. NO TREATMENT INDICATED. 1 PATIENT WITH DISLOCATION. NO TREATMENT INDICATED. 15 PATIENTS WITH WOUND INFECTION/LESION. ONE PATIENT WAS TREATED WITH AN ADDITIONAL SURGICAL INTERVENTION (FIGURE 5). THERE WAS NO MENTION OF INTERVENTION FOR THE REMAINING 14 PATIENTS. 2 PATIENTS WITH HEMATOMA. NO TREATMENT INDICATED. 5 PATIENTS WITH LEG LENGTH DISCREPANCY. NO TREATMENT INDICATED. 1 PATIENT WITH HETEROTOPIC OSSIFICATION. NO TREATMENT INDICATED. 2 PATIENTS WITH DVT. NO TREATMENT INDICATED. ADVERSE EVENT(S) POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL STEM SUMMIT (QTY 2) 2 PATIENTS WITH POST OP MIGRATION (<1CM). NO TREATMENT INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547188 UNKNOWN HIP FEMORAL HEAD HIP FEMORAL HEAD LPH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| R