FDA Adverse Event Injury Summary report: N

SCORPIOFLEX TOTAL KNEE PS

MDR report key: 7876367 · Received September 14, 2018

Report

Report Number: 0002249697-2018-02868
Event Type: Injury
Date Received: September 14, 2018
Date of Event: August 17, 2018
Report Date: September 14, 2018
Manufacturer: STRYKER ORTHOPAEDICS-MAHWAH
Product Code: JWH
UDI-DI: 07613154020287
PMA / PMN Number: K041591
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: SERIES 7000 STANDARD TIBIA; CAT#7115-0009; LOT#T05W128; SCORPIO PS FEMUR WAFFLE W/LFIT; CAT#71-4109L; LOT#K05W182; SCORPIO U-DOME PATELLA; CAT#73-3708; LOT#V288; SIMPLEX P HALF DOSE 1 PACK; CAT#6188-1-001; LOT#RJM357; SIMPLEX P FULL DOSE 1 PACK; CAT#6191-1-001; LOT#RKM375; SIMPLEX P FULL DOSE 1 PACK; CAT#6191-1-001; LOT#RLM383. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE.

Description of Event or Problem · 1

IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED DUE TO INFECTION. THE POLY WAS EXCHANGED FOR THE SAME CATALOG NUMBER. REP PROVIDED A PRIMARY IMPLANT SHEET AND REPORTED THAT HOSPITAL WILL RELEASE NO FURTHER INFORMATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
717305	SCORPIOFLEX TOTAL KNEE PS	PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL	JWH	STRYKER ORTHOPAEDICS-MAHWAH		1ZCXN	07613154020287

Patients

Seq	Age	Sex	Outcome	Treatment
1	80 YR		Hospitalization\| R