BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK STANMORE STEM

    MDR report key: 11723651 · Received April 26, 2021

    Report

    Report Number
    3002806535-2021-00132
    Event Type
    Injury
    Date Received
    April 26, 2021
    Report Date
    June 24, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, H1, H2, H6, H10. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-00131-1, 3002806535-2021-00133-1. ZIMMER BIOMET HAS PROVIDED AN INTERNAL ANALYSES OF LROI OUTLIER THP3 (CEMENTED TOTAL HIP PROSTHESIS FOR OSTEOARTHRITIS WITH ACETABULAR COMPONENT SHP AND FEMORAL COMPONENT STANMORE). BASED ON THE PRESENTED CLINICAL EVIDENCE, REGISTRY DATA, PMS DATA, AND RISK ANALYSIS, THE STANMORE FEMORAL COMPONENTS HAVE BEEN SHOWN TO MEET THEIR INTENDED PURPOSE AS A MODULAR COMPONENT FOR ARTICULATION IN TOTAL HIP ARTHROPLASTY BY REDUCING PAIN AND IMPROVING FUNCTION IN CEMENTED APPLICATIONS, FOR THE SPECIFIED INDICATIONS, AND WITHIN A NORMAL MEDICAL SETTING. THE SAFETY ANALYSIS HAS DEMONSTRATED THAT THE POTENTIAL RISKS ASSOCIATED WITH THE APPROPRIATE USE OF THE DEVICE SYSTEM UNDER EVALUATION ARE JUSTIFIED BASED ON THE BENEFITS FOR THE PATIENT. THERE IS FULL CONSISTENCY BETWEEN THE STATE OF THE ART, THE CLINICAL DATA, THE INFORMATIONAL MATERIALS, MARKETING BROCHURE, AND THE RISK MANAGEMENT FILES. THE CLINICAL DATA PRESENTED IN THIS CLINICAL REPORT SHOW THAT THE SUBJECT DEVICE UNDER EVALUATION MEETS THE RELEVANT MDD ESSENTIAL REQUIREMENTS (ER1, ER3, AND ER6) OF THE MEDICAL DEVICES DIRECTIVE 93/42/EEC AS AMENDED BY DIRECTIVE 2007/47/EC.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE DUTCH REGISTER (LROI) THAT A NUMBER OF PATIENTS UNDERWENT REVISION SURGERY DUE TO LOOSENING, DISLOCATION, INFECTION, WEAR, PERI-PROSTHETIC FRACTURE, GIRDLESTONE SITUATION, PERI-ARTICULAR OSSIFICATION AND OTHER REASONS.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCTS WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. MEDICAL PRODUCT: UNKNOWN SHP ARCOM ACETABULAR CUP, CATALOG #: UNKNOWN, LOT #: UNKNOWN. MEDICAL PRODUCT: UNKNOWN CERAMIC HEAD, CATALOG #: UNKNOWN, LOT #: UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-00131 3002806535-2021-00133. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DUTCH REGISTER (LROI) THAT A NUMBER OF PATIENTS UNDERWENT REVISION SURGERY DUE TO LOOSENING, DISLOCATION, INFECTION, WEAR, PERI-PROSTHETIC FRACTURE, GIRDLESTONE SITUATION, PERI-ARTICULAR OSSIFICATION AND OTHER REASONS. NO FURTHER DETAILS ARE KNOWN FOR THE TIME BEING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622970 UNK STANMORE STEM HIP PROTHESIS JDI BIOMET UK LTD. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE.