E.MOTION PS MENISCAL COMPONENT F6L 10MM

Additional Manufacturer Narrative

MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NB806 - E.MOTION PS MENISCAL COMPONENT F6L 10MM. ACCORDING TO THE COMPLAINT DESCRIPTION, A POSTOPERATIVE EXCHANGE OF THE GLIDING SURFACE WAS PERFORMED DURING WASHOUT FOR INFECTION. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - ADVERSE EVENT (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON THE PATIENT HARM, REVISION SURGERY. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE ADVERSE EVENT IS FILED UNDER AESCULAP AG REFERENCE NO. 400718361.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D6 - IMPLANT DATE H6 - CODES UPDATED INVESTIGATION RESULTS: THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE INVESTIGATION WAS BASED UPON BATCH HISTORY REVIEW, HISTORICAL DATA ANALYSIS, AND EVENT DESCRIPTION AND X-RAY. THE PROVIDED X-RAY FIGURES GIVE ALSO NO HINTS REGARDING THE MENTIONED PROBLEM. BATCH HISTORY REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN CHECKED FOR ALL LEADING DEVICE(S) LOT NUMBERS AND THE PRODUCTS FOUND TO BE ACCORDING TO SPECIFICATION VALID AT THE TIME OF PRODUCTION. THERE ARE NO SIMILAR COMPLAINTS AGAINST THE SAME LOT NUMBER. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - ADVERSE EVENT (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON THE PATIENT HARM, REVISION SURGERY. CONCLUSION/ PREVENTIVE MEASURES: BASED ON THE CURRENT INFORMATION, A CLEAR CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A DESIGN-, MANUFACTURING- AND/OR MATERIAL-RELATED FAILURE. IN THE EVENT THAT THE COMPLAINT SAMPLE WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. THE FOLLOWING CAN BE MENTIONED AS AN INFORMATIONAL NOTE: THE BACTERIA/INFECTION CAN REACH THE PROSTHESIS/BODY IN VARIOUS WAYS, E.G. AS A RESULT OF AN OPERATION, AN INJURY, A PRE-EXISTING BONE INFECTION OR VIA THE BLOODSTREAM IN THE PRESENCE OF OTHER INFLAMMATIONS IN THE BODY. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED.