BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN SCREWS

    MDR report key: 22456137 · Received July 9, 2025

    Report

    Report Number
    0009613350-2025-00559
    Event Type
    Death
    Date Received
    July 9, 2025
    Date of Event
    August 27, 2024
    Report Date
    September 16, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    HWC
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). B2: THE PATIENT EXPIRED AT 6 MONTHS POSTOP. THE DATE IS CURRENTLY UNKNOWN. ATTEMPTS HAVE BEEN MADE TO GATHER THIS INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. B3: EVENT DATE IS THE PUBLICATION DATE OF THE ARTICLE. D4: THE PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER IS NOT APPLICABLE AS THE DEVICE'S PRODUCT NUMBER IS UNKNOWN. D10: UNKNOWN NBC PLATE G2: FRANCE JOURNAL ARTICLE CITATION: BATISTE SANTONI ET AL., ORTHOPAEDICS & TRAUMATOLOGY: SURGERY & RESEARCH, HTTPS://DOI.ORG/10.1016/J.OTSR.2024.104009. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G2, G3, G6, H2, H6, H10, H11. D4: THE PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER IS NOT APPLICABLE AS THE DEVICE'S PRODUCT NUMBER IS UNKNOWN. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. NO PRODUCT WAS RETURNED, AND NO PICTURES WERE PROVIDED; THEREFORE, A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS COULD NOT BE PERFORMED DUE TO MISSING LOT NUMBER. A REVIEW OF THE COMPLAINT HISTORY COULD NOT BE PERFORMED DUE TO MISSING REFERENCE AND LOT NUMBERS. THE ARTICLE DOES NOT PROVIDE A SPECIFIC CAUSE OF DEATH AND DOES NOT CORRELATE THE TREATED COMPLICATION WITH THE DEATH IN ANY WAY. CONTRIBUTING FACTORS TO INFECTION AND DEATH INCLUDE: TRAUMATIC INJURY REQUIRING FIXATION WITH FEMUR FRACTURES OCCURRING MOST PREDOMINANTLY, MOST PATIENTS HAD PRE-EXISTING COMORBID HEALTH COMPLICATIONS, AND AN ELDERLY POPULATION (AVERAGE AGE OF 81 YEARS UP TO 99 YEARS). DURING THE INVESTIGATION PROCESS, A REVIEW OF THE STERILE CERTIFICATIONS COULD NOT BE REVIEWED, AS NO PRODUCT PART/LOT INFORMATION WAS PROVIDED. ALL DEVICES MANUFACTURED FOLLOW ACCEPTABLE STERILIZATION PROCESSES ACCORDING TO PUBLISHED ISO/AAMI/ASTM & EU GUIDELINES. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE THE CONTROL OF ZIMMER BIOMET, SUCH AS EXTERNAL FACTORS, I.E., HOSPITAL/SURGICAL ENVIRONMENT, PROVIDER-RELATED RISK FACTORS, AND/OR PATIENT COMORBIDITIES/RISK FACTORS. AS NO PRODUCT INFORMATION WAS PROVIDED, VALIDATION OF STERILE CERTIFICATIONS CANNOT BE PERFORMED; THEREFORE, THE REPORTED DEVICE CANNOT BE EXCLUDED AS A POSSIBLE SOURCE OF THE REPORTED INFECTION. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    A JOURNAL ARTICLE WAS RETRIEVED FROM ORTHOPAEDICS & TRAUMATOLOGY: SURGERY & RESEARCH (2025) THAT REPORTED A RETROSPECTIVE STUDY FROM FRANCE. THE PURPOSE OF THE STUDY WAS TO PRESENT THE RESULTS OF NCB-PP® LOCKING PLATES IN THE MANAGEMENT OF PERIPROSTHETIC FEMORAL FRACTURES. THE STUDY REVIEWED 89 PATIENTS WITH PERIPROSTHETIC FEMUR FRACTURES BETWEEN JANUARY 2014 AND SEPTEMBER 2022 (74 THA, 11 TKA, AND 4 INTERPROSTHETIC). PATIENTS WERE THEN DIVIDED INTO 2 GROUPS ACCORDING TO THE TIME TO POSTOPERATIVE FULL WEIGHT BEARING: "IMMEDIATE" (30) AND "DELAYED" (59) (A MINIMUM OF 6 WEEKS POST-OPERATIVELY). ALL FRACTURES UNDERWENT ISOLATED NCB-PP® PLATE OSTEOSYNTHESIS USING THE ORIF (OPEN REDUCTION INTERNAL FIXATION) TECHNIQUE VIA A SUB-VASTUS LATERAL APPROACH WITH AN NCB-PP PLATE AND AN UNSPECIFIED NUMBER OF SCREWS. ADDITIONALLY, 38 PATIENTS ALSO RECEIVED CERCLAGE-READY CABLES (ZIMMER BIOMET). THE STUDY POPULATION HAD A MEAN AGE OF 81 YEARS AT TIME OF SURGERY (RANGE 28-99); (62 FEMALES, 27 MALES). MEAN FOLLOW-UP TIME WAS 14.6 MONTHS (RANGE 12-65 MONTHS). THE STUDY REPORTED THAT 1 PATIENT ACQUIRED AN INFECTION AND UNDERWENT SURGICAL LAVAGE WITH APPROPRIATE ANTIBIOTIC THERAPY. THE PATIENT EXPIRED AT 6 MONTHS POSTOP. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124045 UNKNOWN SCREWS SCREW, FIXATION, BONE HWC ZIMMER GMBH UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| D