SMARTSET GHV GENTAMICIN 40G

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY- ACCORDING TO THE INFORMATION RECEIVED, ¿CEMENT CURING TIME IS LONGER THAN USUAL.CEMENT USUALLY GETS HOT AND HARDENS AT 13 MINUTES. IT TOOK 17 MINUTES BEFORE IT HARDENED." NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A RETAINED SAMPLE TEST WAS PERFORMED FOR THIS PRODUCT AND LOT COMBINATION. THE CEMENT MIXED AND BEHAVED AS EXPECTED FOR THE PRODUCT TYPE AND MET THE APPROPRIATE CONTROL SPECIFICATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT- A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT DESCRIPTION SMARTSET GHV GENTAMICIN 40G, PRODUCT CODE: 3095040, LOT NUMBER: 4674653 AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES RELATED TO THE COMPLAINT CONDITION WERE IDENTIFIED. ADDED: D10 CONCOMITANT CORRECTED: D3.

Description of Event or Problem

IT WAS REPORTED THAT THE CEMENT CURING TIME IS LONGER THAN USUAL. CEMENT USUALLY GETS HOT AND HARDENS AT 13 MINUTES. IT TOOK 17 MINUTES BEFORE IT HARDENED. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THERE WERE NO PATIENT CONSEQUENCES.

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: 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.