UNK COTILE SCREW
Received Sep 12, 2022 · Event occurred Mar 19, 2022
Report 0001822565-2022-02625 · MDR key 15402546
Device
Generic name
Prosthesis, Hip
Manufacturer
Zimmer Biomet, Inc.Model number
N/ACatalog number
NI
Lot number
NI
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Unspecified Infection
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
(B)(4). CONCOMITANT MEDICAL PRODUCTS: UNK SCREWS (5). UNK STEM. SHELL CAT#00620206220 LOT#63578798. UNK POLY INSERT. UNK METAL RING. UNK HEAD. FOREIGN: COUNTRY: ITALY. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 0001822565 - 2022 - 02619, 0001822565 - 2022 - 02620, 0001822565 - 2022 - 02621, 0001822565 - 2022 - 02622, 0001822565 - 2022 - 02623, 0001822565 - 2022 - 02624, 0001822565 - 2022 - 02626, 0001822565 - 2022 - 02627, 0001822565 - 2022 - 02628.
Description of Event or Problem
IT WAS REPORTED THE PATIENT PRESENTED WITH PICTURE OF CHRONIC INFECTION TO THE LEFT HIP WITH PRESENCE OF GLUTEAL FISTULA SECRETING PURULENT MATERIAL. IT WAS THEREFORE NECESSARY TO PERFORM PROSTHETIC REMOVAL OF ALL COMPONENTS, WITH FEMORAL OSTEOTOMY SEC. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT 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.