BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP FEMORAL HEAD METAL SROM

    MDR report key: 19774083 · Received July 18, 2024

    Report

    Report Number
    1818910-2024-15390
    Event Type
    Injury
    Date Received
    July 18, 2024
    Date of Event
    April 15, 2024
    Report Date
    July 18, 2024
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: HUANG Y, XIE H, YI J, YANG M, KONG X, CHAI W. IS PELVIC SUPPORT OSTEOTOMY (PSO) SUITABLE FOR ORDINARY HIGH-RIDING HIP DYSPLASIA? INT ORTHOP. 2024 APR 15. DOI: 10.1007/S00264-024-06177-6. EPUB AHEAD OF PRINT. PMID: 38619563. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT 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: HUANG Y, XIE H, YI J, YANG M, KONG X, CHAI W. IS PELVIC SUPPORT OSTEOTOMY (PSO) SUITABLE FOR ORDINARY HIGH-RIDING HIP DYSPLASIA?. INT ORTHOP. 2024 APR 15. DOI: 10.1007/S00264-024-06177-6. EPUB AHEAD OF PRINT. PMID: 38619563. OBJECTIVE/METHODS/STUDY DATA: THIS CASE¿CONTROL STUDY AIMED TO ANALYZE WHETHER PELVIC SUPPORT OSTEOTOMY (PSO) SURGERY IS SUITABLE FOR HIGH-RIDING HIP DYSPLASIA AND SUMMARIZE ORTHOPAEDIC STRATEGY DURING TOTAL HIP ARTHROPLASTY (THA) FOR PATIENTS WITH PREVIOUS PSO. BETWEEN MAY 2018 AND JANUARY 2022, A TOTAL OF 313 PATIENTS WITH HIGH-RIDING DDH WERE INCLUDED IN THE STUDY, INCLUDING 8 PATIENTS WITH PREVIOUS PSO (STUDY GROUP) AND 24 CASES OF HIGH-RIDING HIP DYSPLASIA PATIENTS WITHOUT ANY HIP SURGICAL THERAPY (CONTROL GROUP). THE SURGEONS TRIED TO CHOOSE THE S-ROM FEMORAL PROSTHESIS, WHICH HAS THE FOLLOWING ADVANTAGES: ROTATIONAL STABILITY, ADJUSTABLE ANTEVERSION, AND MATCHING SMALL MEDULLARY CAVITY. ALL SURGERIES WERE PERFORMED BY TWO SENIOR SURGEONS THROUGH A POSTEROLATERAL APPROACH. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: S-ROM FEMORAL PROSTHESIS. OTHER DEVICES THAT WERE USED ON THE PATIENT AT THE TIME OF THE EVENT: ACETABULAR CUP/LINER (MANUFACTURER NOT MENTIONED). ADVERSE EVENT(S) THAT ARE POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL CONSTRUCT SROM (QTY 29) (N=28) TRENDELENBURG SIGN; NO INTERVENTION REPORTED. (N=1) ACUTE PERIPROSTHETIC JOINT INFECTION OCCURRED, WHICH WAS CURED BY DEBRIDEMENT, ANTIBIOTICS, AND IMPLANT RETENTION (DAIR). ADVERSE EVENT(S) THAT ARE POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL CONSTRUCT SROM (QTY 1) A 29-YEAR-OLD FEMALE PATIENT HAD DISTAL FEMUR STEM CORTICAL PERFORATION (X-RAY OF THE PELVIS AFTER THA SHOWING THAT THE PROSTHESIS PENETRATED THE FEMORAL CORTEX), WHICH THE AUTHORS' DID NOT DEAL WITH. THE FOLLOW-UP RESULTS SHOWED THAT THE BONE INGROWTH AT THE PERFORATION RECOVERED. A 41-YEAR-OLD MALE PATIENT HAD PROXIMAL PERIPROSTHETIC FRACTURE OCCURRED DURING THE INSERTION OF THE STEM, THEN THE AUTHORS USED STEEL WIRES TO BUNDLE THE FRACTURE. A 28-YEAR-OLD FEMALE PATIENT HAD A NERVE INJURY AND RECOVERED SPONTANEOUSLY AFTER 1 MONTH. ADVERSE EVENT(S) THAT ARE POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL HEAD SROM (QTY 1) A 35-YEAR-OLD FEMALE PATIENT HAD DISLOCATION ON THE NIGHT AFTER SURGERY, SO THE AUTHORS IMMEDIATELY PERFORMED SURGICAL REDUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555589 UNK HIP FEMORAL HEAD METAL SROM METAL FEMORAL HEAD JDI DEPUY INTERNATIONAL LTD - 8010379

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention UNKNOWN ACETABULAR CUP/LINER