BIOINDUCTIVE IMPLANT W/ARTH DEL LRG

Additional Manufacturer Narrative

INTERNAL REFERENCE NUMBER: CASE-(B)(4). H3, H6: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION REPORTED THAT INCLUDES REFERENCE TO THE USE OF A SMITH+NEPHEW PRODUCT WITHOUT EVIDENCE ABOUT A SPECIFIC PRODUCT PROBLEM. THE REPORTED COMPLICATION RELATES TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE OR IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INVESTIGATIVE FINDINGS OR INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

Description of Event or Problem

IT WAS REPORTED THAT, TWO MONTHS AFTER A ROTATOR CUFF REPAIR, USING THE SUTURE BRIDGE TECHNIQUE, AN MRI DEMONSTRATED COMPLETE LOSS OF THE PREVIOUSLY REPAIRED TENDON. A REVISION SURGERY WAS SUBSEQUENTLY PERFORMED. INTRAOPERATIVE FINDINGS REVEALED THAT THE TENDON HAD DISSOLVED, AND THE ANCHOR SUTURES OF A REGENETEN BIOINDUCTIVE IMPLANT, WHICH ARE NOT DESIGNED TO BE ABSORBABLE, WERE ALSO FOUND TO HAVE DISSOLVED AND DISAPPEARED WITHIN THE PATIENT¿S BODY. AS A RESULT, REMOVAL OF THE REMAINING TISSUE WAS PERFORMED. NO ELEVATION IN LABORATORY VALUES SUGGESTIVE OF INFECTION AND NO CLINICAL SIGNS OF INFLAMMATION WERE OBSERVED. PATIENT'S OUTCOME IS UNKNOWN.