BETA-BSM

Additional Manufacturer Narrative

ZIMMER ETEX COMPLAINT NUMBER (B)(4) HAS BEEN INITIATED TO INVESTIGATE THE EVENT. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED. UNIQUE IDENTIFIER (UDI) NUMBER: (B)(4). CONCOMITANT MEDICAL PRODUCTS - BETA-BSM CATALOG#: 76-6016, LOT#: 102112, SERIAL#'S: (B)(4). THE DEVICE WAS LEFT IMPLANTED.

Description of Event or Problem

IT WAS REPORTED THE PATIENT UNDERWENT A PROCEDURE FOR A BENIGN HUMERAL CYST. DURING INTER-OSSEOUS, THE PATIENTS VITALS BECAME UNSTABLE AND WAS TRANSFERRED TO A LEVEL 1 TRAUMA CENTER AND LATER EXPIRED. PER AN EMAIL FROM THE SURGEON, "THE MEDICAL EXAMINER DEFINED THE CAUSE OF DEATH AS LIKELY DUE TO ACUTE CEMENT EMBOLISM SYNDROME."

Description of Event or Problem

DURING THE SURGERY PATIENT VITALS WERE IN CONCERN AND PATIENT DIED.

Additional Manufacturer Narrative

DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED NO ACTION IS NECESSARY AS NO TRENDS WERE IDENTIFIED. A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED. ASSOCIATED RISKS ARE ADDRESSED IN RISK DOCUMENTATION. THERE IS NO EVIDENCE OF PRODUCT NONCONFORMANCE AND IT DOES NOT APPEAR THAT THE CAUSE OF THE DEATH IS RELATED TO PRODUCT PERFORMANCE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER ETEX WILL CONTINUE TO MONITOR FOR TRENDS.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A1; A4; B4; B5; G4; G7; H1; H2. ADDITIONAL INFORMATION DOES NOT CHANGE THE RESULTS OF THE PREVIOUS INVESTIGATION. 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.