FAST-FIX/IMPLANTS
Received Mar 9, 2011
Report 1219602-2011-00035 · MDR key 2012398
Device
Generic name
Unknown Fast-fix
Manufacturer
Smith & Nephew Endoscopy Mansfield ManufactureModel number
0002Catalog number
0002
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
DURING A LITERATURE REVIEW, IT WAS NOTED THAT THERE WERE MULTIPLE INCIDENTS IDENTIFYING POST-OPERATIVE REACTIONS INVOLVING NUMEROUS UNKNOWN PATIENTS. THEREFORE WE ARE FILING ONE MEDWATCH REPORT WHICH REPRESENTS THIS INCIDENT. IF ADDITIONAL INDIVIDUAL PATIENT INFORMATION BECOMES AVAILABLE AT A LATER DATE; WE WILL REVIEW THE DATA AND EVALUATE ACCORDINGLY. (B)(4)
Description of Event or Problem
DURING THE LITERATURE REVIEW FOR ABSORBABLE IMPLANTS, SOFT TISSUE FIXATION A PIECE OF LITERATURE WAS FOUND WITH THE FOLLOWING COMPLAINTS: 5 PATIENTS HAD TO UNDERGO REVISION SURGERY AND HAD PARTIAL MENISECTOMIES. . HAAS AL, SCHEPSIS AA, HORNSTEIN J, EDGAR CM. MENISCAL REPAIR USING THE FAST-FIX ALL-INSIDE MENISCAL REPAIR DEVICE. ARTHROSCOPY. 2005 FEB; 21(2):167-75. (B)(4)