SMARTSET GHV GENTAMICIN 40G

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, D10 (CONCOMITANT). CORRECTED: D3. 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: A. CAN YOU PLEASE CONFIRM THE ALERT DATE? - THE ALERT DATE IS CORRECT.

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 WAS RECEIVED PROVIDING ANSWERS FROM THE FOLLOWING QUESTIONS: CAN YOU PLEASE CONFIRM THE ALERT DATE? CONFIRM ALERT DATE SAME AS DOCUMENT. HOW WAS THE CEMENT PREPARED FOR USE? STORAGE IN OPERATING ROOM. WHAT EQUIPMENT WAS USED TO PREPARE / MIX THE CEMENT? CEMENT CUP. WHAT WAS THE TIMING TO MIX AND THE TIME BETWEEN MIXING AND SETTING? 30 SECONDS TO MIX, 1-2 MINUTES TO SETTING. WHAT EQUIPMENT WAS USED TO DELIVER THE CEMENT? CLEAN BOX IN OPERATING ROOM. WHAT WAS THE STORAGE TEMPERATURE OF THE CEMENT PRIOR TO USAGE? 19 C STORAGE TEMPERATURE. WHAT WAS THE OR TEMPERATURE DURING USE OF THE CEMENT? 18 C OR TEMPERATURE. KINDLY CONFIRM THE ACCOUNT NAME? (B)(6).

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.

Description of Event or Problem

IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY (TKA). DURING THE PROCEDURE, THE CEMENT DID NOT CLUMP TOGETHER. CHANGED TO A NEW BOX. THERE WAS AN UNKNOWN SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4) INVESTIGATION SUMMARY NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. ACCORDING TO THE INFORMATION RECEIVED, ¿DOES NOT CLUMP TOGETHER AND I". LOT: 4617341 MANUFACTURING DATE: 06 NOV 2024 EXPIRY DATE: 31 OCT 2026 QUANTITY: (B)(4) PRODUCT CHECKED: RETAINED SAMPLES. REQUIRED TESTING: TM-T150 CEMENT SETTING TIME THERE ARE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT. THE SAMPLES WERE TESTED IN A TEMPERATURE AND HUMIDITY-CONTROLLED LABORATORY (SEE PAGE 2). LOT: 4617341 DOUGH TIME: 52S (SPEC: MAX 1 MIN 30S) MIX CHARACTERISTICS: FIRM SETTING TIME: 9 MINS 08S (SPEC: 8 MIN 30S TO 12 MIN 30S) THE CEMENT MIXED AND BEHAVED AS EXPECTED FOR THE PRODUCT TYPE AND MET THE APPROPRIATE CONTROL SPECIFICATION (REF: MS-010 BONE CEMENT: MASTER SPECIFICATION: SMARTSET GHV GENTAMICIN BONE CEMENT). 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 THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.