UNK
Received Jun 21, 2023 · Event occurred Jan 2, 2023
Report 1220246-2023-06947 · MDR key 17171068
Device
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
NA · Unknown
- Foreign Body Reaction
- Foreign Body Reaction
Narrative
Additional Manufacturer Narrative
THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
ON 5/30/2023, IT WAS REPORTED BY A PATIENT VIA PHONE THAT OVER A YEAR AND A HALF AGO, AN ARTHREX IBALANCE PRODUCT WAS IMPLANTED DURING A TOTAL KNEE REPLACEMENT PROCEDURE. IN (B)(6) OF 2023, THE PATIENT UNDERWENT REVISION SURGERY DUE TO PAIN, DISINTEGRATION OF CARTILAGE, AND IMPLANT REJECTION. THE PATIENT WAS REFERRED TO AN ALLERGY SPECIALIST FOR FURTHER TESTING BUT THE PATIENT HAS NOT ATTENDED A CONSULT. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED VIA EMAIL.
Additional Manufacturer Narrative
BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A PATIENT-SPECIFIC EVENT.