UNKNOWN UNCEMENTED AVENIR-MÜLLER STEM

Description of Event or Problem

A JOURNAL ARTICLE WAS OBTAINED THAT REPORTED A SINGLE CENTER, RETROSPECTIVE STUDY FROM FRANCE. THE PRIMARY OBJECTIVE OF THIS STUDY WAS TO ASSESS EARLY SUBSIDENCE OF A CEMENTLESS FEMORAL STEM. SECONDARY OBJECTIVES WERE TO IDENTIFY PREDICTIVE FACTORS FOR SUBSIDENCE, DISLOCATION, AND PERIOPERATIVE FRACTURE. THE STUDY REVIEWED 117 CONSECUTIVE PATIENTS BETWEEN 2013 AND 2016, OVER 65 YEARS OF AGE, WHO UNDERWENT SYSTEMATIC IMPLANTATION OF AN UNCEMENTED AVENIR-MÜLLER STEM. A TOTAL HIP ARTHROPLASTY (THA) WAS PERFORMED 47 TIMES AND AN INTERMEDIATE HIP ARTHROPLASTY (IHA) 70 TIMES. INTRAOPERATIVE CERCLAGE WIRING WAS USED IN 5 CASES. THE STUDY POPULATION HAD A MEAN AGE OF 83.1 YEARS AT TIME OF SURGERY; (23 MALES/94 FEMALES). EPIDEMIOLOGICAL AND RADIOLOGICAL DATA WERE COLLECTED AT 6 WEEKS AND 3 MONTHS POSTOPERATIVELY. THE LITERATURE REPORTED AT THREE MONTHS, RADIOGRAPHIC IMAGING DISPLAYED A MEAN AVERAGE OF 1.4MM SUBSIDENCE, OF WHICH INCLUDED 22 PATIENTS WITH > 2MM SUBSIDENCE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

Additional Manufacturer Narrative

(B)(4). 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: CONCOMITANT MEDICAL PRODUCTS: ITEM: UNKNOWN - UNKNOWN HEAD - LOT: UNKNOWN. ITEM: UNKNOWN - UNKNOWN LINER - LOT: UNKNOWN. ITEM: UNKNOWN - UNKNOWN CUP - LOT: UNKNOWN. G2: FOREIGN - EVENT OCCURRED IN FRANCE. G2: LITERATURE - VIBERT B, DREVET S, KERSCHBAUMER G, SEURAT O, TONETTI J, BOUDISSA M. CEMENTLESS FEMORAL STEM IN ARTHROPLASTY FOR HIP FRACTURE: EARLY RADIOLOGICAL SUBSIDENCE AT 3 MONTHS AND PREDICTIVE FACTOR OUT OF 117 CASES. ORTHOP TRAUMATOL SURG RES. 2026 MAY;112(3):104589. DOI: 10.1016/J.OTSR.2026.104589. 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.