ARTHREX DX MATRIX
Received Aug 9, 2017 · Event occurred Apr 22, 2017
Report 2530154-2017-00004 · MDR key 6776998
Device
Generic name
Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
Manufacturer
Dsm BiomedicalModel number
30031-02Lot number
E0361
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
66 YR
- Erythema
- Fever
- Pain
- Fluid Discharge
- Erythema
- Fever
- Pain
- Fluid Discharge
Narrative
Additional Manufacturer Narrative
A DESIGN HISTORY REVIEW WAS CONDUCTED. THE PRODUCT MET ALL ACCEPTANCE CRITERIA; PACKAGING AND STERILIZATION WERE PERFORMED IN ACCORDANCE WITH PRE-DETERMINED, VALIDATED PARAMETERS. DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
IT WAS REPORTED APPROXIMATELY 2 WEEKS AFTER IMPLANTATION THAT THE PATIENT COMPLAINED ABOUT "AFFLICTIONS": FEVER (39.6°); SHIVERS; WOUND WAS RED WITH SECRETIONS; PAINFUL RESTRICTION OF MOTION. SECOND ARTHROSCOPIC SURGERY WAS NECESSARY. ARTHREX DX WAS REMOVED; SURGEON DID A DEBRIDEMENT AND A LAVAGE, AND INSERTED A DRAIN. A SPECIMEN WAS COLLECTED WHICH DID NOT SHOW ANY MICROBIOLOGIC CORRELATIVE GERMS. THREE DAYS LATER, SURGEON DID ANOTHER LAVAGE AND INSERTED A NEW DRAIN. PATIENT REMAINED IN THE HOSPITAL FOR 12 DAYS AFTER THE SECOND SURGERY. THE DEVICE WAS DISCARDED BY THE FACILITY BECAUSE IT WAS "PUTRID".