SIMPLEX P-JAPANESE TWIN PACK

Report

Report Number: 0002249697-2014-04115
Event Type: Malfunction
Date Received: November 3, 2014
Date of Event: September 25, 2014
Report Date: October 8, 2014
Manufacturer: STRYKER ORTHOPAEDICS-MAHWAH
Product Code: LOD
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THIS DEVICE IS NOT CLEARED FOR SALE IN THE UNITED STATES BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE FOR SALE IN THE UNITED STATES. NOT AVAILABLE.

Additional Manufacturer Narrative · 1

AN EVENT REGARDING SETTING TIME INVOLVING SIMPLEX BONE CEMENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION AND FUNCTIONAL TESTING WAS COMPLETED ON THREE RETAIN SAMPLES OF THE REPORTED LOT. THE RESULTS WERE SATISFACTORY AND WITHIN SPECIFICATION. MEDICAL RECORDS RECEIVED AND EVALUATION: NO MEDICAL RECORDS WERE RECEIVED OR WERE RELEVANT TO THE INVESTIGATION OF THIS EVENT. DEVICE HISTORY REVIEW: BMR REVIEW FOR THE SPECIFIED LOT INDICATES THAT THE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: CHR REVIEW DETERMINED THAT THERE WERE NO OTHER SIMILAR EVENTS REPORTED FOR THE REFERENCED LOT. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT THE REPORTED SETTING TIME ISSUE CANNOT BE CONFIRMED. THE MIXING PROPERTIES OF THE RETAIN SAMPLES OF THE REPORTED LOT CODE WERE TESTED AND SHOW THAT ALL REQUIRED SPECIFICATIONS ARE MET. THE MIXING CHARACTERISTICS AND WORKING PROPERTIES OF SIMPLEX BONE CEMENTS ARE INFLUENCED PRIMARILY BY THE TEMPERATURE OF THE LIQUID AND POWDER COMPONENTS AT THE TIME OF MIXING AND BY THE TEMPERATURES OF THE UTENSILS WITH WHICH IT CONTACTS DURING MIXING E.G. MIXING BOWLS, CEMENT INTRODUCERS ETC. GENERALLY, HIGHER TEMPERATURES ACCELERATE THE POLYMERIZATION REACTION AND LOWER TEMPERATURES DELAY IT. OTHER FACTORS WHICH CAN AFFECT SETTING TIME ARE MIXING TECHNIQUE (SPEED, USE OF VACUUM, CENTRIFUGATION), THOROUGHNESS OF MIXING, COMPLETE UTILIZATION OF ALL OF THE POWDER & LIQUID AND CARE TO AVOID INCLUSION OF ANY EXTRANEOUS MATERIAL SUCH AS BLOOD OR STERILIZATION SOLUTIONS INTO THE MIX. MIXING PROCESS/TECHNIQUE ISSUES ARE HIGHLIGHTED IN THE OR HANDBOOK. BASED ON THE LABORATORY RESULTS OF THE RETAIN SAMPLES IT IS NOT POSSIBLE TO REPLICATE THIS EVENT. IT IS NOTED THAT ANTIBIOTIC WAS ADDED TO THE CEMENT BY THE CUSTOMER.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE CEMENT HARDENED FOR ABOUT 5~6 MIN USING FOR CEMENT MOLDING. 3 PACS OF CEMENT WERE STORED IN THE REFRIGERATOR 10 DEGREES REFRIGERATOR AND USED. 1 OF THE 3 PACS OF THE CEMENT WAS STORED IN THE REFRIGERATOR OF THE HOSPITAL. 2 OF 3 PACS OF THE CEMENT WAS STORED IN THE 20 DEGREES ROOM IN THE DEALERSHIP. THE OPERATING ROOM TEMP WAS BELOW 24 DEGREES. SPARE CEMENT WAS USED(3 PACS OF CEMENT AND THEY WERE STORED IN THE 20 DEGREES ROOM IN THE DEALERSHIP.) .SPARE CEMENT DID NOT HARDENED FAST.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE CEMENT HARDENED FOR ABOUT 5~6 MIN USING FOR CEMENT MOLDING. 3 PACS OF CEMENT WERE STORED IN THE REFRIGERATOR 10 DEGREES REFRIGERATOR AND USED. 1 OF THE 3 PACS OF THE CEMENT WAS STORED IN THE REFRIGERATOR OF THE HOSPITAL. 2 OF 3 PACS OF THE CEMENT WAS STORED IN THE 20 DEGREES ROOM IN THE DEALERSHIP. THE OPERATING ROOM TEMP WAS BELOW 24 DEGREES. SPARE CEMENT WAS USED (3 PACS OF CEMENT AND THEY WERE STORED IN THE 20 DEGREES ROOM IN THE DEALERSHIP.) SPARE CEMENT DID NOT HARDENED FAST.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
703149	SIMPLEX P-JAPANESE TWIN PACK	IMPLANT	LOD	STRYKER ORTHOPAEDICS-MAHWAH		JCV010

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other