SMARTSET GHV GENTAMICIN 40G

Description of Event or Problem

VISCOSITY OF CEMENT AFTER MIXING WAS LOWER THAN USUAL AND IT TOOK MORE THAN FIFTEEN MINUTES FOR CEMENT HARDENING WHEN USUALLY IT WAS SUFFICIENTLY HARDENED BY THIRTEEN MINUTES.

Additional Manufacturer Narrative

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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL NARRATIVE: DMF# - 13704. TRADE NAME ¿ GENTAMICIN SULPHATE. ACTIVE INGREDIENT(S) ¿ GENTAMICIN SULPHATE. DOSAGE FORM - POWDER. STRENGTH ¿ 1.0G ACTIVE IN OUR CEMENTS. G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO DEVICE MARKETED IN THE USA.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY - AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION, THEREFORE IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTIVE ACTION IS REQUIRED AT THIS TIME. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. H11 ADDITIONAL NARRATIVE: ADDED: D10.