EXCEED ABT 3HL SHELL 48/60MM
Received Aug 29, 2018 · Event occurred Sep 20, 2017
Report 3002806535-2018-01034 · MDR key 7827251
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
70 YR
- Unspecified Infection
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
(B)(4). CONCOMITANT MEDICAL PRODUCTS - MEDICAL PRODUCT - 36MM 12/14 TPR FEM HD STD NK, ITEM 650-0888, LOT 388226, THERAPY DATE - (B)(6) 2017, OLYMPIA STEM SIZE 5 RIGHT, ITEM 650-0635, LOT 3220851, THERAPY DATE - (B)(6) 2017. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). 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: 3002806535-2018-01035 AND 3002806535-2018-01036.
Description of Event or Problem
IT WAS REPORTED BY THE NJR THAT A PATIENT UNDERWENT AN INITIAL RIGHT HIP ARTHROPLASTY AND SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO INFECTION.
Additional Manufacturer Narrative
(B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE EVENT WERE FOUND. 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
IT WAS REPORTED BY THE NJR THAT A PATIENT UNDERWENT AN INITIAL RIGHT HIP ARTHROPLASTY AND SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO INFECTION.