E-POLY 36MM +3 HIWALL LINER SZ23

Additional Manufacturer Narrative

(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 09876, 0001825034 - 2018 - 09877, 0001825034 - 2018 - 09878.

Description of Event or Problem

IT WAS REPORTED PATIENT DEVELOPED INFECTION, CAUSING INCISIONAL DRAINAGE 2 WEEKS POST-OPERATIVE INITIAL HIP PROCEDURE. PATIENT WAS TREATED WITH ORAL ANTIBIOTICS. THE DRAINAGE RESOLVED AND INCISION WAS WELL HEALED BY 7 WEEK FOLLOW UP. NO FURTHER TREATMENT REQUIRED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS RECEIVED. PROGRESS NOTES STATED THE PATIENT DEVELOPED INFECTION, CAUSING INCISIONAL DRAINAGE 2 WEEKS POSTOPERATIVELY. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES THAT WOULD CONTRIBUTE TO REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.