BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR LINERS

    MDR report key: 19420371 · Received May 29, 2024

    Report

    Report Number
    1818910-2024-11790
    Event Type
    Injury
    Date Received
    May 29, 2024
    Date of Event
    January 22, 2024
    Report Date
    May 29, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    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. 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. H6: COMPONENT CODE: APPROPRIATE TERM/CODE NOT AVAILABLE (G07002) USED TO CAPTURE NO FINDINGS AVAILABLE. 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: DAI H, DENG Z, YANG L, SONG C, YU G, LUO J, XU J. ENDOSCOPIC ARTHROPLASTY VIA MINI-OPEN DIRECT ANTERIOR APPROACH IMPROVES POSTOPERATIVE COMPLICATIONS AND ACETABULAR COMPONENTS OF TOTAL HIP ARTHROPLASTY IN OBESE PATIENTS. ORTHOP SURG. 2024 APR;16(4):998-1009. DOI: 10.1111/OS.14015. EPUB 2024 FEB 21. PMID: 38384138; PMCID: PMC10984812. OBJECTIVE/METHODS/STUDY DATA: THE PURPOSE OF THIS STUDY WAS TO COMPARE THE CLINICAL AND RADIOGRAPHIC OUTCOMES IN OBESE PATIENTS SUBJECTED TO THA BETWEEN ENDO-DAA, BIKINI DAA, AND CONVENTIONAL DAA. 360 HIPS WERE INCLUDED AND WERE IMPLANTED WITH CORAIL STEMS AND PINNACLE CUPS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: UNKNOWN HIP FEMORAL HEAD, UNK HIP FEMORAL STEM CORAIL, UNKNOWN HIP ACETABULAR LINERS, AND UNK HIP ACETABULAR CUP PINNACLE ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP ACETABULAR CUP PINNACLE (QTY 1): CUP ANTEVERSION AND ABDUCTION OUTSIDE ¿SAFE ZONE¿. NO INTERVENTION NOTED. (QTY 1) ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL STEM CORAIL (QTY 62): 37 HIPS WITH INTRA-OP BLOOD LOSS REQUIRING TRANSFUSION. LEG LENGTH DISCREPANCY REPORTED. NO INTERVENTION NOTED. (QTY 1) 9 HIPS WITH VENOUS THROMBOSIS. NO INTERVENTION NOTED. 2 HIPS WITH SURGICAL SITE INFECTION. NO INTERVENTION NOTED. 4 HIPS WITH WOUND DEHISCENCE. NO INTERVENTION NOTED. 3 HIPS WITH HEMATOMA TREATED WITH REVISION. 3 HIPS WITH PERIPROSTHETIC FRACTURE. NO INTERVENTION NOTED. 3 HIPS LCFN DYSESTHESIA (NERVE INJURY). NO INTERVENTION NOTED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN HIP ACETABULAR LINERS CORAIL (QTY 58): 37 HIPS WITH INTRA-OP BLOOD LOSS REQUIRING TRANSFUSION. 9 HIPS WITH VENOUS THROMBOSIS. NO INTERVENTION NOTED. 2 HIPS WITH SURGICAL SITE INFECTION. NO INTERVENTION NOTED. 4 HIPS WITH WOUND DEHISCENCE. NO INTERVENTION NOTED. 3 HIPS WITH HEMATOMA TREATED WITH REVISION. 3 HIPS LCFN DYSESTHESIA (NERVE INJURY). NO INTERVENTION NOTED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN HIP FEMORAL HEAD (QTY 59): 37 HIPS WITH INTRA-OP BLOOD LOSS REQUIRING TRANSFUSION. LEG LENGTH DISCREPANCY REPORTED. NO INTERVENTION NOTED. (QTY 1) 9 HIPS WITH VENOUS THROMBOSIS. NO INTERVENTION NOTED. 2 HIPS WITH SURGICAL SITE INFECTION. NO INTERVENTION NOTED. 4 HIPS WITH WOUND DEHISCENCE. NO INTERVENTION NOTED. 3 HIPS WITH HEMATOMA TREATED WITH REVISION. 3 HIPS LCFN DYSESTHESIA (NERVE INJURY). NO INTERVENTION NOTED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP ACETABULAR CUP PINNACLE (QTY 58): 37 HIPS WITH INTRA-OP BLOOD LOSS REQUIRING TRANSFUSION. 9 HIPS WITH VENOUS THROMBOSIS. NO INTERVENTION NOTED. 2 HIPS WITH SURGICAL SITE INFECTION. NO INTERVENTION NOTED. 4 HIPS WITH WOUND DEHISCENCE. NO INTERVENTION NOTED. 3 HIPS WITH HEMATOMA TREATED WITH REVISION. 3 HIPS LCFN DYSESTHESIA (NERVE INJURY). NO INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1825337 UNKNOWN HIP ACETABULAR LINERS HIP ACETABULAR LINERS LPH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention