InjuryOLC
9.0MM CMI - MEDIAL (INTERNATIONAL)
Received Mar 21, 2018 · Event occurred Jan 5, 2018
Report 0002956141-2018-00001 · MDR key 7360191
Device
Generic name
Scaffold, Partial Medial Meniscal Defects Extending Into The Red/white Zone, Res
Manufacturer
Stryker Endoscopy-san JoseCatalog number
4601
Lot number
UNKNOWN
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Pain
- Pain
Narrative
Additional Manufacturer Narrative
THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. ALLEGED FAILURE: PATIENT GOT PAIN SINCE IMPLANTATION AND PATELLA BRUISE PROBABLE ROOT CAUSE: INFECTION ASSOCIATED WITH ANY ARTHROSCOPIC PROCEDURE. THE DEVICE MANUFACTURER DATE IS NOT KNOWN. (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT REVISION SURGERY IS NECESSARY DUE TO PATIENT PAIN..