SMARTSET GHV GENTAMICIN 20G

Additional Manufacturer Narrative

PRODUCT COMPLAINT #(B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: ADDED: B5. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

ADDITIONAL INFORMATION RECEIVED: 1.THE CEMENT CANNOT BE MIXED IF THE POWDER IS MISSING FROM THE KIT, SO WHAT IS MEANT BY "THE POWDER COMPONENT WAS MISSING"? WAS THE POWDER COMPONENT ACTUALLY MISSING ENTIRELY FROM THE PACKAGE? OR WAS THERE LESS THAN THE USUAL QUANTITY OF THE POWDER IN THE KIT? -THERE WAS NO LIQUID OR POWDER MISSING. THE MIXTURE DID NOT WENT AS USUAL. THE TWO INGREDIENTS CLITT TOGETHER AND IT WAS DIFFICULT TO ACTIVATE A HOMOGENEOUS MIXTURE. 2.WERE THERE ANY PATIENT HARMS OR CONSEQUENCES AS A RESULT OF THIS EVENT? -NOT REPORTED.

Description of Event or Problem

IT WAS REPORTED THAT DURING PREPARATION FOR A TOTAL KNEE ARTHROPLASTY PROCEDURE, THE POWDER COMPONENT WAS MISSING AND THE LIQUID DID NOT BEHAVE AS EXPECTED DURING PREPARATION. THE MIDTUBE BEGAN TO CLUMP SPONTANEOUSLY AND HARDER LUMPS FORMED, PREVENTING PROPER MIXING. HERE WAS NO REPORTED PATIENT HARM OR SIGNIFICANT SURGICAL DELAY AS A RESULT OF THIS EVENT.

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: D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.