MCK TIBIAL ONLAY INSERT- SZ 4- 9MM
Received Feb 24, 2015 · Event occurred Jan 19, 2015
Report 3005985723-2015-00016 · MDR key 4538105
Device
Generic name
Compartmental Knee Prosthesis
Manufacturer
Mako Surgical Corp.Catalog number
180704-2
Lot number
12020611-3
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Unspecified Infection
- Complaint, Ill-Defined
- No Code Available
- No Code Available
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 SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE NOT RETURNED; DISCARDED.
Additional Manufacturer Narrative
AN EVENT REGARDING INFECTION INVOLVING A RESTORIS MCK INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION COULD NOT BE PERFORMED AS THE SUBJECT DEVICE WAS NOT RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW WAS NOT PERFORMED AS NO DEVICE SPECIFIC FAILURE MODES WERE IDENTIFIED. CONCLUSIONS: INFECTION IS MOST LIKELY A RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE IN THE HEALTHCARE FACILITY SETTING, HOWEVER, THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME 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.