VITELENE INSERT H 36MM SYM.
Received May 22, 2026 · Event occurred May 15, 2026
Report 9610612-2026-00115 · MDR key 25255683
Device
Generic name
Hip Endoprosthetics
Manufacturer
Aesculap AgModel number
NV214ECatalog number
NV214E
Lot number
52699461
Product problems
- Inadequacy of Device Shape and/or Size
Patient
NA · Male
- Failure of Implant
Narrative
Description of Event or Problem
AN ADVERSE EVENT WAS REPORTED INVOLVING THE MEDICAL DEVICE NV214E - VITELENE INSERT H 36MM SYM. SPECIFICALLY, IT WAS REPORTED THAT APPROXIMATELY FOUR YEARS AFTER THE INITIAL IMPLANTATION SURGERY IN (B)(6) 2022, REVISION SURGERY WAS PERFORMED TO REPLACE THE VITALENE INSERT. ACCORDING TO THE HEALTHCARE FACILITY, THE INSERT MAY NOT HAVE BEEN PROPERLY SECURED DURING THE INITIAL IMPLANTATION PROCEDURE. 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, REVISION SURGERY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AESCULAP AG REFERENCE NO. 100042422 ((B)(4)).
Additional Manufacturer Narrative
MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.