UNKNOWN COMPONENT OF AESCULAP AG VEGA KNEE IMPLANT SYSTEM
Received Dec 11, 2025
Report 9610612-2025-00294 · MDR key 23782837
Device
Product problems
- Patient-Device Incompatibility
- Patient-Device Incompatibility
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5 - DESCRIPTION UPDATED. D6 - IMPLANTATION DATE.
Description of Event or Problem
UPDATE: THE DATE OF INITIAL SURGERY WAS (B)(6) 2023. THE REVISION HAS NOT YET BEEN PERFORMED; THE PATIENT STATED THAT SHE IS WAITING ON IT.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: A SECTION- PATIENT DATA. H6 - CODES UPDATED. INVESTIGATION RESULTS: THE COMPLAINED PRODUCT WAS NOT MADE AVAILABLE FOR INVESTIGATION. THE INVESTIGATION WAS BASED UPON HISTORICAL DATA ANALYSIS AND EVENT DESCRIPTION. BATCH HISTORY REVIEW: THE BATCH NUMBER WAS NOT PROVIDED. EVEN AFTER FAITHFUL ATTEMPTS, FURTHER INFORMATION WAS NOT RECEIVED. 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. CONCLUSION/PREVENTIVE MEASURES: BASED ON THE CURRENT INFORMATION, A CLEAR ROOT CAUSE CONCLUSION 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. BASED UPON INVESTIGATION RESULTS, A CAPA IS NOT NECESSARY.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH AN UNKNOWN COMPONENT OF AESCULAP AG VEGA KNEE IMPLANT SYSTEM. ACCORDING TO THE COMPLAINT DESCRIPTION, A REVISION OR POLYSWAP WAS PLANNED DUE TO "NOT HEALED AND IT'S NOT TAKING". THE KNEE REPLACEMENT HAD BEEN IMPLANTED IN (B)(6) 2023. 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 BUT HAS BEEN REQUESTED. THE ADVERSE EVENT IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4).
Additional Manufacturer Narrative
MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.