MCK TIBIAL ONLAY INSERT- SZ 5- 9MM
Received Apr 27, 2015 · Event occurred Mar 25, 2015
Report 3005985723-2015-00053 · MDR key 4730880
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
Patient
Not reported
- Unspecified Infection
- Injury
Narrative
Description of Event or Problem
A PATIENT HAD RECEIVED A PARTIAL KNEE ARTHROPLASTY, WHICH WAS PERFORMED USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. APPROXIMATELY ONE MONTH LATER, THE PATIENT PRESENTED WITH SIGNS OF A POSSIBLE INFECTION, AND THE SURGEON PERFORMED AN INCISION AND DRAINAGE (I&D) PROCEDURE AND EXCHANGED THE TIBIAL ONLAY INSERT COMPONENT.
Additional Manufacturer Narrative
AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED BY MAKO. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. NOT PROVIDED BY HOSPITAL.
Additional Manufacturer Narrative
REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THE LOT WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 21-MAY-2014. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. PATIENT DETAILS WERE REVIEWED AND NO INDICATION WAS FOUND THAT THE EVENT WAS RELATED TO DEVICE DESIGN, MATERIALS, OR MANUFACTURING. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.
Description of Event or Problem
A PATIENT HAD RECEIVED A PARTIAL KNEE ARTHROPLASTY, WHICH WAS PERFORMED USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. APPROXIMATELY ONE MONTH LATER, THE PATIENT PRESENTED WITH SIGNS OF A POSSIBLE INFECTION, AND THE SURGEON PERFORMED AN INCISION AND DRAINAGE (I&D) PROCEDURE AND EXCHANGED THE TIBIAL ONLAY INSERT COMPONENT.