SMARTSET GHV GENTAMICIN 20G

Description of Event or Problem

SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION LEFT KNEE. DEVICE RELATED: POSSIBLE. PROCEDURE RELATED: POSSIBLE. DATE OF EVENT: 15 NOV 2021 DATE OF IMPLANT: (B)(6) 2019. DATE OF REVISION: (B)(6) 2021. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: HOSPITALIZATION, REVISION OF STUDY JOINT, COMPONENTS REMOVED (ATTUNE FEMORAL COMPONENT, ATTUNE TIBIAL INSERT, ATTUNE TIBIAL BASE, ATTUNE TIBIAL STEM, ATTUNE TIBIAL SLEEVE).

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. G4: "DMF# - 13704; TRADE NAME ¿ GENTAMICIN SULPHATE; ACTIVE INGREDIENT(S) ¿ GENTAMICIN SULPHATE; DOSAGE FORM - POWDER; STRENGTH ¿ 1.0G ACTIVE IN OUR CEMENTS." IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.