BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AS COLUMBUS REV F TIB.OFFSET CEMENT.T1

    MDR report key: 22903389 · Received August 27, 2025

    Report

    Report Number
    9610612-2025-00187
    Event Type
    Injury
    Date Received
    August 27, 2025
    Date of Event
    May 24, 2023
    Report Date
    September 16, 2025
    Manufacturer
    AESCULAP AG
    Product Code
    JWH
    PMA / PMN Number
    K083772
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6 - CODES UPDATED. INVESTIGATION FINDINGS: THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE INVESTIGATION WAS BASED UPON BATCH HISTORY REVIEW, HISTORICAL DATA ANALYSIS, AND EVENT DESCRIPTION. BATCH HISTORY REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN CHECKED FOR ALL LEADING DEVICE(S) LOT NUMBERS AND THE PRODUCTS FOUND TO BE ACCORDING TO SPECIFICATION VALID AT THE TIME OF PRODUCTION. THERE ARE NO SIMILAR COMPLAINTS AGAINST THE SAME LOT NUMBER. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - ADVERSE EVENT (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON THE PATIENT HARM, PERMANENT IMPAIRMENT. CONCLUSION/PREVENTIVE MEASURES: ON THE BASIS OF THE CURRENT INFORMATION, A CONCLUSION REGARDING THE PATIENT'S PAIN AND HIGH BLOOD PRESSURE CANNOT BE DRAWN. THERE IS NO INDICATION FOR A DESIGN-, MANUFACTURING- AND/OR MATERIAL-RELATED FAILURE. IN THE EVENT THAT THE COMPLAINT SAMPLE WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. THERE ARE SEVERAL POSSIBLE RISKS, SIDE EFFECTS AND INTERACTIONS OF THE APPLICATION. THIS IS ALSO POINTED OUT IN THE INSTRUCTIONS FOR USE (IFU) (AESCULAP AG INTERNAL REFERENCE NUMBER (B)(4) 2021-09 CHANGE NO. (B)(4)): 2.3 RISKS, ADVERSE EFFECTS AND INTERACTIONS - WITHIN THE SCOPE OF THE LEGAL OBLIGATION TO PROVIDE INFORMATION, REFERENCE IS MADE TO THE TYPICAL RISKS, INTERACTIONS AND SIDE EFFECTS LISTED BELOW. POSSIBLE RISKS, SIDE EFFECTS AND INTERACTIONS OF THE APPLICATION CURRENTLY KNOWN TO THE MANUFACTURER ARE: - DISLOCATION, LOOSENING, WEAR, CORROSION, DISCONNECTION AND BREAKAGE OF THE IMPLANT COMPONENTS. - MALALIGNMENT OF ANATOMICAL STRUCTURES, INCLUDING LOSS OF CORRECT KNEE ALIGNMENT, LOSS OF VARUS AND/OR VALGUS CORRECTION. - DECREASE IN BONE DENSITY OR LOSS OF BONE SUBSTANCE DUE TO RESORPTION OR STRESS SHIELDING. - SKIN OR MUSCLE SENSITIVITY IN PATIENTS WITH INSUFFICIENT TISSUE COVERAGE AT THE OPERATION SITE. - JOINT DISLOCATION AND POSTOPERATIVE CHANGES IN LEG LENGTH. - PRIMARY AND SECONDARY INFECTIONS. - PERIPROSTHETIC FRACTURES. - THROMBOSES, EMBOLISMS. - TISSUE REACTION TO IMPLANT MATERIALS. - INJURY TO THE SURROUNDING TISSUE, INCLUDING NERVE AND VASCULAR DAMAGE. -HAEMATOMA AND WOUND HEALING DISORDERS. -PERIARTICULAR CALCIFICATION, PERIARTICULAR ADHESION AND FIBROSIS. - REDUCED JOINT MOBILITY AND FLEXIBILITY. - LIMITED LOAD-BEARING ABILITY OF THE JOINT AND JOINT PAIN. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PRODUCT NR071Z - AS COLUMBUS REV F TIB.OFFSET CEMENT.T1. ACCORDING TO THE COMPLAINT DESCRIPTION, THE PATIENT HAS HAD CHRONIC PAIN FOR THE PAST 16 YEARS. THE LAST LEFT KNEE REVISION WAS ON 04MAY2023, WHEN AESCULAP PRODUCTS HAD BEEN IMPLANTED. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - ADVERSE EVENT (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON THE PATIENT HARM, PERMANENT IMPAIRMENT. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE ADVERSE EVENT IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4)). ASSOCIATED MEDWATCH REPORTS: NR293Z (AESCULAP AG REFERENCE NO. (B)(4); 9610612-2025-00153). NR044Z (AESCULAP AG REFERENCE NO. (B)(4); 9610612-2025-00185). NR003Z (AESCULAP AG REFERENCE NO. (B)(4); 9610612-2025-00186). NR071Z (AESCULAP AG REFERENCE NO. (B)(4) ). NR244Z (AESCULAP AG REFERENCE NO. (B)(4); 9610612-2025-00188). NR193Z (AESCULAP AG REFERENCE NO. (B)(4); 9610612-2025-00189). NR563Z (AESCULAP AG REFERENCE NO. (B)(4); 9610612-2025-00190). NR400Z (AESCULAP AG REFERENCE NO. (B)(4); 9610612-2025-00191). INVOLVED COMPONENT: NR612M/ COLUMBUS REV F HC GLID.SURF.T1/1+ 14MM (AESCULAP AG REFERENCE NO. (B)(4)). BONE CEMENT (NON-AESCULAP). BONE VOID FILLER (NON- AESCULAP).

    Description of Event or Problem · 0

    UPDATE: ASSOCIATED MEDWATCH REPORTS: NR293Z (AESCULAP AG REFERENCE NO. (B)(4); 9610612-2025-00153). NR044Z (AESCULAP AG REFERENCE NO. (B)(4); 9610612-2025-00185). NR003Z (AESCULAP AG REFERENCE NO. (B)(4); 9610612-2025-00186). NR071Z (AESCULAP AG REFERENCE NO. (B)(4); 9610612-2025-00187). NR244Z (AESCULAP AG REFERENCE NO. (B)(4); 9610612-2025-00188). NR193Z (AESCULAP AG REFERENCE NO. (B)(4); 9610612-2025-00189). NR563Z (AESCULAP AG REFERENCE NO. (B)(4); 9610612-2025-00190). NR400Z (AESCULAP AG REFERENCE NO. (B)(4); 9610612-2025-00191). NR612M (AESCULAP AG REFERENCE NO. (B)(4); 9610612-2025-00227). INVOLVED COMPONENTS: BONE CEMENT (NON-AESCULAP). BONE VOID FILLER (NON- AESCULAP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1380550 AS COLUMBUS REV F TIB.OFFSET CEMENT.T1 KNEE ENDOPROSTHETICS JWH AESCULAP AG NR071Z 52644064

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Disability NR612M - LOT 52510557.