BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN REFLECTION METAL CUP

    MDR report key: 13863694 · Received March 23, 2022

    Report

    Report Number
    1020279-2022-01275
    Event Type
    Injury
    Date Received
    March 23, 2022
    Date of Event
    August 9, 2020
    Report Date
    April 12, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). ZHOU, X., CHEN, M., YU, W., HAN, G., YE, J., & ZHUANG, J. (2020). UNCEMENTED VERSUS CEMENTED TOTAL HIP ARTHROPLASTY FOR DISPLACED FEMORAL NECK FRACTURES IN ELDERLY PATIENTS WITH OSTEOPOROSIS: A RETROSPECTIVE ANALYSIS. JOURNAL OF INTERNATIONAL MEDICAL RESEARCH, 48(8), 0300060520944663. DOI: 10.1177/0300060520944663.

    Additional Manufacturer Narrative · 0

    H3, H6: THE DEVICES WERE NOT RETURNED FOR EVALUATION AND THE REPORTED EVENTS COULD NOT BE CONFIRMED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT, WITHOUT CLINICALLY RELEVANT PATIENT-SPECIFIC SUPPORTING DOCUMENTATION, A THOROUGH MEDICAL INVESTIGATION COULD NOT BE PERFORMED. THE ROOT CAUSE AND/OR PATIENTS OUTCOME BEYOND THAT WHICH WAS DOCUMENTED IN THE ARTICLE COULD NOT BE CONFIRMED NOR CONCLUDED; THEREFORE, NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. SHOULD CLINICAL DOCUMENTATION BECOME AVAILABLE IN THE FUTURE, A THOROUGH MEDICAL ASSESSMENT MAY BE RENDERED AT THAT TIME. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCTS FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. FACTORS AND/OR SOME POTENTIAL PROBABLE CAUSES THAT COULD CONTRIBUTE TO THE REPORTED EVENT HAVE BEEN IDENTIFIED AS OVERUSE OR EXCESSIVE PRESSURE ON THE JOINT, INFECTION, PATIENTS CONDITION, ABNORMAL MOTION OVER TIME, BONE DEGENERATION, PATIENTS ANATOMY, ABNORMAL LOADING OF LIMB, FIT/SIZING ISSUE, LACK OF INGROWTH, TRAUMATIC INJURY, EXCESSIVE FORCES APPLIED TO IMPLANT AND SURGICAL TECHNIQUE. THE CONTRIBUTION OF THE DEVICES TO THE REPORTED EVENTS COULD NOT BE CORROBORATED. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. WITHOUT THE RETURN OF THE ACTUAL PRODUCTS INVOLVED, OUR INVESTIGATION COULD NOT PROCEED. SHOULD THE DEVICES OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON LITERATURE REVIEW ""UNCEMENTED VERSUS CEMENTED TOTAL HIP ARTHROPLASTY FOR DISPLACED FEMORAL NECK FRACTURES IN ELDERLY PATIENTS WITH OSTEOPOROSIS: A RETROSPECTIVE ANALYSIS"", 144 PATIENTS HAD A THR WITH A REFLECTION CUP. OF THESE, SIXTEEN (16) HAD A PROTHESIS REVISION FOR UNKNOWN REASONS, TWENTY THREE (23) A PROTHESIS LOOSENING, FOURTEEN (14) A PERIPROSTHETIC FRACTURE AND SEVEN(7) PRESENTED DISLOCATION. IT IS UNKNOWN HOW THIS ADVERSE EVENTS WERE TREATED. PATIENTS OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727673 UNKN REFLECTION METAL CUP PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL JDG SMITH & NEPHEW, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| H