BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN WAGNER STEM

    MDR report key: 21772636 · Received April 4, 2025

    Report

    Report Number
    0009613350-2025-00226
    Event Type
    Injury
    Date Received
    April 4, 2025
    Report Date
    April 24, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT (B)(4). UPDATED: B4, B5, D2, G1, G3, G6, H1, H2, H6 CORRECTED: B1 NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; 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. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CAN BE CONFIRMED. JOURNAL ARTICLE REPORTS THAT A PATIENT WITHIN THE FCTS GROUP THAT DEMONSTRATED STEM SUBSIDENCE ON IMAGING. ANY INTERVENTION REQUIRED AND FURTHER DETAILS SURROUNDING THIS EVENT ARE CURRENTLY UNKNOWN. THEREFORE, A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). B3: DATE EVENT: BETWEEN 1, JAN,2006 TO 31, DEC,2012 D10: UNKNOWN HEAD, UNKNOWN CUP, UNKNOWN LINER. THERAPY DATE: UNKNOWN. G2: REPORT SOURCE SPAIN. REPORT SOURCE: "HERNÁNDEZ-MATEO, J.M.; OROZCO-MARTÍNEZ, J.; MATAS-DÍAZ, J.A.; VAQUERO, F.J.; SANZ-RUIZ, P. COMPARISON OF CYLINDRICAL AND TAPERED STEM DESIGNS FOR FEMORAL REVISION HIP ARTHROPLASTY. J. CLIN. MED. 2024, 13, 1745. HTTPS://DOI.ORG/10.3390/JCM13061745." 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 MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION.

    Description of Event or Problem · 0

    ON 17MAR2025, A JOURNAL ARTICLE WAS RETRIEVED FROM JOURNAL OF CLINICAL MEDICINE 2024 THAT REPORTED A STUDY FROM SPAIN. THE PURPOSE OF THE STUDY WAS TO DETERMINE WHETHER THERE ARE ANY LONG-TERM DIFFERENCE BETWEEN CYLINDRICAL FULLY COATED COBALT-CHROMIUM STEMS (CCS) AND MONOBLOCK FLUTED CONICAL TAPERED STEMS (FCTS) IN TERMS OF IMPLANT SURVIVAL, RADIOLOGICAL FINDINGS SUGGESTIVE OF LOOSENING, AND FUNCTIONAL OUTCOMES. THE RETROSPECTIVE STUDY REVIEWED 38 CCS (COMPETITOR PRODUCT) VERSUS 40 FCTS (ZIMMER) USED IN ISOLATED REVISIONS OF THE FEMORAL HIP COMPONENT COMPLETED WITH AN UNCEMENTED MONOBLOCK STEM COMPILED FROM A PROSPECTIVE DATABASE BETWEEN 2006-2012 WITH POSTEROLATERAL APPROACH IN ALL CASES. SURGICAL TECHNIQUE WAS THE SAME IN ALL PATIENTS, EXCEPT THE ASPECTS SPECIFIC TO THE REAMING OF EACH TYPE OF STEM. FEMORAL OSTEOTOMY WAS NOT NEEDED IN 27 OF THE FCTS GROUP; 2 REQUIRED TROCHANTERIC AND 11 REQUIRED EXTENDED TROCHANTERIC OSTEOTOMIES (ETO) DUE TO DIFFICULT EXTRACTION OF THE PREVIOUS STEM OR WHEN DEFORMITY OF THE PROXIMAL FEMUR COULD IMPEDE CORRECT IMPLANTATION OF THE NEW STEM. THE INDICATION FOR REVISION/SURGERY WAS VARIED AND FOR THE FCTS GROUP INCLUDED ASEPTIC LOOSENING (20), INFECTION (5), PERIPROSTHETIC FRACTURE (6), OSTEOSYNTHESIS FAILURE (5), RECURRENT DISLOCATION (1), AND TWO-STAGE REVISION FOR UNKNOWN REASON (3). ALL 40 OF THE FCTS HAD SOME LEVEL OF PAPROSKY FEMORAL DEFECT: 20 TYPE 2, 18 TYPE IIIA, AND 2 TYPE IIIB; 48.3% OF WHICH REQUIRED SOME LEVEL OF BONE GRAFTING TO ADDRESS. THE STUDY POPULATION HAD A MEAN AGE OF 71.38 YEARS AT TIME OF SURGERY; 21 MALES/19 FEMALES. FOLLOW-UP MUST HAVE BEEN CONDUCTED FOR A MINIMUM OF 10 YEARS OR THE PATIENT WAS NOT REVIEWED FOR STUDY PURPOSES, MEAN FOLLOW-UP TIME FOR FCTS WAS 126.6 MONTHS. IT WAS REPORTED THAT A PATIENT WITHIN THE FCTS GROUP THAT DEMONSTRATED STEM SUBSIDENCE ON IMAGING. ANY INTERVENTION REQUIRED AND FURTHER DETAILS SURROUNDING THIS EVENT ARE CURRENTLY UNKNOWN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686576 UNKNOWN WAGNER STEM HIP PROSTHESIS LZO ZIMMER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other SEE H11 NARRATIVE.