9.0MM CMI - MEDIAL
Received Dec 4, 2017 · Event occurred Oct 24, 2017
Report 0002956141-2017-00005 · MDR key 7080891
Device
Generic name
Collagen Meniscus Implant Xl
Manufacturer
Stryker Endoscopy-san JoseCatalog number
4301
Lot number
16G473
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). THIS RECORD WAS FILED ON BEHALF OF THE LEGAL MANUFACTURER, (B)(4). THE DEVICE MANUFACTURE DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS. ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem
IT WAS REPORTED REVISION SURGERY WAS PERFORMED DUE TO A POP FELT BY PATIENT AFTER INITIAL SURGERY.
Additional Manufacturer Narrative
ALLEGED FAILURE: AFTER MEDICAL PROCEDURE PATIENT FELT A POP PROBABLE ROOT CAUSE: SURGICAL TRAINING (SURGEON TRAINED IN SPECIFIC SURGICAL TECHNIQUES FOR CMI IMPLANTATION). THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. GTIN: (B)(4). THE DEVICE MANUFACTURER DATE IS NOT KNOWN.
Description of Event or Problem
IT WAS REPORTED REVISION SURGERY WAS PERFORMED DUE TO A POP FELT BY PATIENT AFTER INITIAL SURGERY.