COLLECT.NO.QAS KNEE IMPLANTS VEGA
Received Mar 23, 2018 · Event occurred Apr 24, 2018
Report 9610612-2018-00130 · MDR key 7365463
Device
Generic name
Gliding Surfaces/patellas Vega Syst
Manufacturer
Aesculap Implant SystemsModel number
AE-QAS-K521-56Catalog number
AE-QAS-K521-56
Product problems
- Loose or Intermittent Connection
- Loose or Intermittent Connection
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
EXEMPTION NUMBER: E2014018. EVALUATION ON-GOING. DEVICE NOT RETURNED.
Description of Event or Problem
COUNTRY OF COMPLAINT: USA. IT WAS REPORTED THAT THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2016, BUT THE SURGEON NOTICED THAT THE TIBIA HAD LOOSENED. REVISION SURGERY DATE IS UNKNOWN AT THIS TIME.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: INITIAL INFORMATION RECEIVED RELATED TO THIS EVENT WAS INCORRECT. THE PATIENT ASSOCIATED WITH THIS REPORT DID NOT EXPERIENCE A LOOSENING OF ANY COMPONENT OF THE KNEE IMPLANT. ORIGINAL MEDWATCH REPORT SUBMITTED WITH INACCURATE INFORMATION. NO MEDWATCH REPORT REQUIRED. NO ADDITIONAL INFORMATION WILL BE PROVIDED RELATED TO THIS REPORT.