BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN. SL-PLUS FAMILY STEM (UNKN. SUB-FAMILY)

    MDR report key: 11851966 · Received May 19, 2021

    Report

    Report Number
    9613369-2021-00257
    Event Type
    Injury
    Date Received
    May 19, 2021
    Date of Event
    January 1, 2011
    Report Date
    June 29, 2021
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS AG
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE STUDY OF CHEN, D., ET. AL. [1] REPORTS THE OUTCOME OF HIP ARTHROPLASTY USING A CEMENTLESS THREADED CUP AND A CEMENTLESS STRAIGHT STEM IN PATIENTS WITH HIGH CONGENITAL HIP DISLOCATION. BETWEEN (B)(6) 2001 AND (B)(6) 2004, 17 PATIENTS WITH HIGH CONGENITAL HIP DISLOCATION WERE TREATED. IT IS REPORTED, THAT IN ONE CASE THE PATIENT SUFFERED FROM AN INTRAOPERATIVE FEMORAL FRACTURE, REQUIRING CERCLAGE WIRING. THE COMPLAINT DEVICE, USED IN TREATMENT, WAS NOT RETURNED FOR INVESTIGATION, HENCE THE PRODUCT EVALUATION COULD NOT BE CONDUCTED. A COMPLAINT HISTORY REVIEW WAS PERFORMED. THE BATCH RECORD REVIEW COULD NOT BE PERFORMED AS THE BATCH NUMBER OF THE DEVICE IS NOT KNOWN. THE SEVERITY AND THE FAILURE MODE ARE COVERED THROUGH OUR RISK MANAGEMENT. THE REPORTED FAILURE MODE MIGHT OCCUR IN SOME CASES, WHICH IS STATED AS A SIDE EFFECT IN THE INSTRUCTIONS FOR USE. NO PATIENT INFORMATION NOR ANY OTHER MEDICATION DOCUMENTATION WAS PROVIDED, THEREFORE, A THOROUGH MEDICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON OUR INVESTIGATIONS THE FAILURE MODE COULD NOT BE CONFIRMED INDEPENDENTLY. A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE CANNOT BE CONFIRMED. DUE TO INSUFFICIENT INFORMATION IT IS NEITHER POSSIBLE TO INVESTIGATE WHETHER THE REPORTED DEVICE MET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION NOR TO SPECULATE ABOUT FACTORS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE ROOT CAUSE OF THE PROBLEM STAYS UNDETERMINED. TO DATE, NO FURTHER ACTIONS WILL BE TAKEN. SMITH AND NEPHEW WILL MONITOR THE DEVICES FOR FURTHER SIMILAR ISSUES. THIS INVESTIGATION IS CONSIDERED CLOSED. [1]: CHEN D, XU Z, SHI D, QIU X, DAI J, YUAN T, WENG W, JIANG Q. CLINICAL OUTCOME OF ZWEYMÜLLER TOTAL HIP ARTHROPLASTY FOR PATIENTS WITH HIGH CONGENITAL HIP DISLOCATION. HIP INT. 2011 JAN-MAR;21(1):71-5. DOI: 10.5301/HIP.2011.6279. PMID: (B)(6).

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW, INC. IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED UPON INFORMATION WHICH SMITH & NEPHEW, INC. HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW, INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    ON THE LITERATURE ARTICLE NAMED "CLINICAL OUTCOME OF ZWEYMÜLLER TOTAL HIP ARTHROPLASTY FOR PATIENTS WITH HIGH CONGENITAL HIP DISLOCATION", IT WAS REPORTED THAT, AFTER A SL-PLUS FAMILY STEM HAD BEEN IMPLANTED ON 1 PATIENT, THE PATIENT TREATED WITH THE ZWEYMULLER BICON SYSTEM SUFFERED FROM AN INTRAOPERATIVE FEMORAL FRACTURE, REQUIRING CERCLAGE WIRING. THE OUTCOME OF THE PATIENT WAS NOT REPORTED. THE PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746464 UNKN. SL-PLUS FAMILY STEM (UNKN. SUB-FAMILY) UNKN. SL-PLUS FAMILY STEM (UNKN. SUB-FAMILY) JDI SMITH & NEPHEW ORTHOPAEDICS AG UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R