UNKN REGENETEN BIOINDUCTIVE IMPLANT SYSTEM INSTR

Description of Event or Problem

IT WAS REPORTED THAT ON AN ABSTRACT OF A LITERATURE REVIEW "52-P16-9", 1 PATIENT HAD A ROTATOR CUFF REPAIR PERFORMED USING A REGENETEN BIOINDUCTIVE IMPLANT. THE PATIENT HAD RECURRENCE OF SYMPTOMS (NOCTURNAL PAIN) AND FIRST AN MRI WAS PERFORMED WERE NO ISSUES WERE FOUND. HOWEVER, (B)(6) ULTRASONOGRAPHY REVEALED THAT ALTHOUGH THE PATCH APPEARED NORMAL IN THE RESTING ARM DOWN POSITION, IT SHIFTED AWAY FROM THE ROTATOR CUFF ATTACHMENT AND ADHERED TO THE DELTOID MUSCLE DURING ARM ELEVATION¿CONFIRMING DISPLACEMENT OF THE IMPLANT. IT IS UNKNOWN HOW WAS THE PATIENT WAS TREATED. PATIENT OUTCOME UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE (B)(4). H11 H3, H6: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION IDENTIFIED THROUGH A REVIEW OF CLINICAL EVIDENCE FROM LITERATURE SOURCES THAT INCLUDES REFERENCE TO THE USE OF A SMITH+NEPHEW PRODUCT. THE REPORTED ISSUE(S) RELATE 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 CONSERVATIVELY SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.