POLARSTEM COLLAR STD. TI/HA 0

Additional Manufacturer Narrative

INTERNAL REFERENCE NUMBER: (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, AFTER A THR PERFORMED ON (B)(6) 2019, THE PATIENT EXPERIENCED GROIN PAIN DUE TO EARLY DEGENERATIVE CHANGES IN THE LUMBAR BACK, POSSIBLY RELATED TO TENDONITIS. THE PATIENT RECEIVED PHYSICAL THERAPY AND A STEROID INJECTION AS TREATMENT. THE PATIENT IS CURRENTLY RECOVERING.

Additional Manufacturer Narrative

H2: CORRECTED INFORMATION IN H6 (TYPE OF INVESTIGATION) AND H11 (RESULTS OF INVESTIGATION). H3, H6: THE COMPLAINT DEVICE USED IN TREATMENT WAS NOT RETURNED FOR INVESTIGATION. A PRODUCT EVALUATION WAS NOT POSSIBLE. A REVIEW OF THE PRODUCTION DOCUMENTATION DID NOT DETECT ANY DEVIATION THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. THE REVIEW OF HISTORICAL COMPLAINTS FOR THE ALLEGED DEVICE REVEALED NO ADDITIONAL SIMILAR COMPLAINTS REPORTED FOR THE SAME BATCH, AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE SAME PRODUCT NUMBER OVER THE PAST 12 MONTHS WITH A SIMILAR FAILURE MODE. A REVIEW OF PAST ESCALATION ACTIONS FOUND NO EVENTS APPLICABLE TO THIS COMPLAINT. A REVIEW OF THE RISK MANAGEMENT DOCUMENTATION VERIFIES THE FAILURE MODE, OCCURRENCE AND SEVERITY OF THE REPORTED ISSUE. THE INSTRUCTIONS FOR USE STATES [AIN AS A ¿POSSIBLE SIDE EFFECTS¿ RESULTING FROM A HIP ARTHROPLASTY. ALTHOUGH A HOST OF FACTORS CAN CONTRIBUTE TO GROIN PAIN, THE REPORTED DEGENERATIVE LUMBAR SPINE CHANGES POSSIBLY RELATED TO TENDONITIS CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. THE DEFINITIVE CLINICAL ROOT CAUSE CANNOT BE CONCLUDED BASED ON THE LIMITED INFORMATION PROVIDED WITHIN THE CRF OPERATIVE PAGES. THE PATIENT IMPACT INCLUDED SPECIFICALLY THE GROIN PAIN WITH SUBSEQUENT PT AND STEROID INJECTION. THE CHRONICITY OF THE PAIN, DEGENERATIVE CHANGES AND TENDONITIS IS UNKNOWN. REPORTEDLY, THE PATIENT IS CURRENTLY RECOVERING. THE PERFORMED INVESTIGATION DOES NOT LEAD TO AN ACCURATELY DETERMINED CAUSE. THERE IS NO INDICATION THAT THE REPORTED DEVICES FAILED TO MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. THERE IS NO NEED FOR FURTHER ACTIONS BECAUSE OF THE LIMITED INFORMATION PROVIDED. NEVERTHELESS, SMITH+NEPHEW WILL CONTINUE TO MONITOR THIS DEVICE FOR SIMILAR ISSUES. THIS COMPLAINT WILL BE REOPENED SHOULD ADDITIONAL INFORMATION OR THE DEVICE BE RECEIVED.