BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK CEMENT CMW

    MDR report key: 21960180 · Received May 5, 2025

    Report

    Report Number
    1818910-2025-07024
    Event Type
    Malfunction
    Date Received
    May 5, 2025
    Date of Event
    May 3, 2024
    Manufacturer
    DEPUY IRELAND - 3015516266
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY ORTHOPAEDICS IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY ORTHOPAEDICS HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY ORTHOPAEDICS OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY ORTHOPAEDICS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. THE DEVICE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT/LOT NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KO CY, TSAI CH, FONG YC, CHEN HY, CHEN HT, LIN TL. EFFECT OF SURGEON VOLUME ON MECHANICAL COMPLICATIONS AFTER RESECTION ARTHROPLASTY WITH ARTICULATING SPACER. J PERS MED. 2024 MAY 3;14(5):490. DOI: 10.3390/JPM14050490. PMID: 38793072; PMCID: PMC11122508. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THE STUDY IS TO COMPARE THE RATES OF MECHANICAL COMPLICATIONS AND REOPERATION AFTER RA WITH ARTICULATING SPACERS BY SURGEONS WITH HIGH VOLUMES (HV) AND LOW VOLUMES (LV) OF RA PERFORMED AND ANALYZED THE RISK FACTORS FOR MECHANICAL FAILURE. THE STUDY POPULATION WAS RETROSPECTIVELY DERIVED FROM A DATABASE AND INCLUDED 278 ADULT PATIENTS WITH CHRONIC PKI, BASED ON THE MUSCULOSKELETAL INFECTION SOCIETY CRITERIA, WHO UNDERWENT A TWO-STAGE REVISION WITH PS SPACERS BETWEEN JANUARY 2015 AND MARCH 2022, WITH A MINIMUM FOLLOW-UP OF 1 YEAR. IN THE SURGICAL TECHNIQUE, ALL ANTIBIOTIC-LOADED CEMENT SPACERS WERE PREPARED USING A 1:5 RATIO OF ANTIBIOTICS TO BONE CEMENT (CMW3; DEPUY SYNTHES, WARSAW, IN, USA). THE AVERAGE FOLLOW-UP TIME WAS 54.1 MONTHS. ALL SPACERS WERE IMPLANTED USING A ROUTINE MEDIAL PARAPATELLAR APPROACH. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY CMW3 OTHER DEVICES THAT WERE USED ON THE PATIENT AT THE TIME OF THE EVENT: ARTICULATING SPACERS; CADAS; EVERYOUNG BIODIMENSIONS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK KNEE CONSTRUCT (QTY.5) A 68-YEAR-OLD MALE HAD PERIPROSTHETIC TIBIAL FRACTURE AFTER 3 WEEKS. TIBIAL SPACER EXCHANGE WAS THE INTERVENTION. A 73-YEAR-OLD MALE HAD PERIPROSTHETIC TIBIAL FRACTURE AFTER 4 WEEKS. BOTH SPACER EXCHANGE WAS THE INTERVENTION. A 60-YEAR-OLD MALE HAD PERIPROSTHETIC TIBIAL FRACTURE AFTER 6 WEEKS. UNEXPECTED EARLY REIMPLANTATION WAS THE INTERVENTION. A 77-YEAR-OLD FEMALE HAD EXTENSOR MECHANISM DISRUPTION AFTER 3 WEEKS. TIBIAL SPACER EXCHANGE WAS THE INTERVENTION. A 67-YEAR-OLD MALE HAD EXTENSOR MECHANISM DISRUPTION AFTER 4 WEEKS. LATERAL RELEASE WAS THE INTERVENTION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK CEMENT CMW (QTY.35) A 69-YEAR-OLD FEMALE HAD TIBIAL SPACER MIGRATION AFTER 3 WEEKS. HINGE KNEE BRACE WAS THE INTERVENTION. A 75-YEAR-OLD FEMALE HAD TIBIAL SPACER MIGRATION AFTER 3 WEEKS. TIBIAL SPACER EXCHANGE WAS THE INTERVENTION. A 68-YEAR-OLD FEMALE HAD TIBIAL SPACER MIGRATION AFTER 4 WEEKS. TIBIAL SPACER EXCHANGE WAS THE INTERVENTION. A 69-YEAR-OLD MALE HAD TIBIAL SPACER MIGRATION AFTER 4 WEEKS. BOTH SPACERS EXCHANGE WAS THE INTERVENTION. A 73-YEAR-OLD FEMALE HAD TIBIAL SPACER MIGRATION AFTER 3 WEEKS. TIBIAL SPACER EXCHANGE WAS THE INTERVENTION. A 60-YEAR-OLD FEMALE HAD TIBIAL SPACER MIGRATION AFTER 5 WEEKS. TIBIAL SPACER EXCHANGE WAS THE INTERVENTION. A 66-YEAR-OLD MALE HAD TIBIAL SPACER MIGRATION AFTER 3 WEEKS. TIBIAL SPACER EXCHANGE WAS THE INTERVENTION. A 76-YEAR-OLD FEMALE HAD TIBIAL SPACER MIGRATION AFTER 6 WEEKS. UNEXPECTED EARLY REIMPLANTATION WAS THE INTERVENTION. A 64-YEAR-OLD FEMALE HAD TIBIAL SPACER MIGRATION AFTER 6 WEEKS. UNEXPECTED EARLY REIMPLANTATION WAS THE INTERVENTION. A 64-YEAR-OLD MALE HAD TIBIAL SPACER FRACTURE AFTER 4 WEEKS. HINGE KNEE BRACE WAS THE INTERVENTION. A 76-YEAR-OLD MALE HAD TIBIAL SPACER FRACTURE AFTER 5 WEEKS. BOTH SPACERS EXCHANGE WAS THE INTERVENTION. A 73-YEAR-OLD MALE HAD TIBIAL SPACER FRACTURE AFTER 2 WEEKS. HINGE KNEE BRACE WAS THE INTERVENTION. A 72-YEAR-OLD FEMALE HAD BOTH SPACERS (TIBIAL & FEMORAL) FRACTURE AFTER 6 WEEKS. UNEXPECTED EARLY REIMPLANTATION WAS THE INTERVENTION. A 72-YEAR-OLD FEMALE HAD BOTH SPACERS (TIBIAL & FEMORAL) FRACTURE AFTER 3 WEEKS. HINGE KNEE BRACE WAS THE INTERVENTION. A 63-YEAR-OLD MALE HAD FEMORAL SPACERS FRACTURE AFTER 4 WEEKS. BOTH SPACERS EXCHANGE WAS THE INTERVENTION. A 77-YEAR-OLD FEMALE HAD JOINT DISLOCATION AFTER 6 WEEKS. UNEXPECTED EARLY REIMPLANTATION WAS THE INTERVENTION. A 63-YEAR-OLD FEMALE HAD JOINT DISLOCATION AFTER 4 WEEKS. OPEN REDUCTION WAS THE INTERVENTION. AN 86-YEAR-OLD FEMALE HAD JOINT DISLOCATION AFTER 6 WEEKS. TIBIAL SPACER EXCHANGE WAS THE INTERVENTION. A 77-YEAR-OLD FEMALE HAD JOINT DISLOCATION AFTER 4 WEEKS. TIBIAL SPACER EXCHANGE WAS THE INTERVENTION. A 71-YEAR-OLD MALE HAD JOINT DISLOCATION AFTER 5 WEEKS. TIBIAL SPACER EXCHANGE WAS THE INTERVENTION. A 72-YEAR-OLD MALE HAD JOINT DISLOCATION AFTER 4 WEEKS. BOTH SPACERS EXCHANGE WAS THE INTERVENTION. AN 80-YEAR-OLD FEMALE HAD JOINT DISLOCATION AFTER 6 WEEKS. BOTH SPACERS EXCHANGE WAS THE INTERVENTION. A 66-YEAR-OLD FEMALE HAD JOINT DISLOCATION AFTER 7 WEEKS. FEMORAL SPACER EXCHANGE WAS THE INTERVENTION. A 60-YEAR-OLD MALE HAD JOINT DISLOCATION AFTER 4 WEEKS. FEMORAL SPACER EXCHANGE WAS THE INTERVENTION. AN 80-YEAR-OLD FEMALE HAD JOINT DISLOCATION AFTER 8 WEEKS. FEMORAL SPACER EXCHANGE WAS THE INTERVENTION. A 67-YEAR-OLD FEMALE HAD JOINT DISLOCATION AFTER 4 WEEKS. FEMORAL SPACER EXCHANGE WAS THE INTERVENTION. A 61-YEAR-OLD MALE HAD JOINT DISLOCATION AFTER 3 WEEKS. BOTH SPACERS EXCHANGE WAS THE INTERVENTION. A 72-YEAR-OLD MALE HAD JOINT DISLOCATION AFTER 6 WEEKS. BOTH SPACERS EXCHANGE WAS THE INTERVENTION. A 66-YEAR-OLD MALE HAD JOINT SUBLUXATION AFTER 5 WEEKS. HINGE KNEE BRACE WAS THE INTERVENTION. AN 82-YEAR-OLD MALE HAD JOINT SUBLUXATION AFTER 4 WEEKS. HINGE KNEE BRACE WAS THE INTERVENTION. A 66-YEAR-OLD FEMALE HAD JOINT SUBLUXATION AFTER 3 WEEKS. TIBIAL SPACER EXCHANGE WAS THE INTERVENTION. A 68-YEAR-OLD FEMALE HAD JOINT SUBLUXATION AFTER 5 WEEKS. HINGE KNEE BRACE WAS THE INTERVENTION. A 58-YEAR-OLD MALE HAD JOINT SUBLUXATION AFTER 7 WEEKS. HINGE KNEE BRACE WAS THE INTERVENTION. A 61-YEAR-OLD MALE HAD JOINT SUBLUXATION AFTER 4 WEEKS. HINGE KNEE BRACE WAS THE INTERVENTION. A 73-YEAR-OLD FEMALE HAD JOINT SUBLUXATION AFTER 5 WEEKS. HINGE KNEE BRACE WAS THE INTERVENTION. THIS REPORT CAPTURES A 69-YEAR-OLD FEMALE WHO HAD TIBIAL SPACER MIGRATION AFTER 3 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475504 UNK CEMENT CMW BONE CEMENT LOD DEPUY IRELAND - 3015516266

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female