CROSSFIRE 10 DEG INSERT

MDR report key: 4585548 · Received March 10, 2015

Report

Report Number: 0002249697-2015-00667
Event Type: Injury
Date Received: March 10, 2015
Date of Event: August 20, 2014
Report Date: February 12, 2015
Manufacturer: STRYKER ORTHOPAEDICS-MAHWAH
Product Code: JDI
PMA / PMN Number: K97685
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

UPDATE: THIS EVENT HAS BEEN IDENTIFIED AS A DUPLICATE OF (B)(4). THE EVENT WAS REPORTED UNDER 2249697-2010-00113.

Additional Manufacturer Narrative · 1

ADDITIONAL DEVICES LISTED IN THIS REPORT: CAT 2051-2058P, SECUR-FIT PSL CUP/CLUS, LOT CODE 67069101; CAT 2030-6520-1, 6.5 CANCELLOUS BONE SCREW 20MM, LOT CODE 715376036; CAT 2030-6525-1, 6.5 CANCELLOUS BONE SCREW 25MM, LOT CODE 70148301; CAT 6098-0735, OMNIFIT EON 132, LOT CODE 71396401; CAT 1067-0014, OSTEONICS UNIV. DISTAL SPACER, LOT CODE 1N1003; CAT B004-0155, OSTEONICS SIZED CEMENT-PLUG, LOT CODE 1N7004; CAT 06-3200, C-TAPER COCR LFIT HEAD 32MM/0, LOT CODE 72239201. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. IT WAS NOTED THAT THE DEVICES ARE NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

Description of Event or Problem · 1

PATIENT WAS REVISED DUE TO INFECTED LEFT HIP.

Description of Event or Problem · 1

PATIENT WAS REVISED DUE TO INFECTED LEFT HIP. UPDATE: THIS EVENT HAS BEEN IDENTIFIED AS A DUPLICATE OF (B)(4). THE EVENT WAS REPORTED UNDER 2249697-2010-00113.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
165875	CROSSFIRE 10 DEG INSERT	IMPLANT	JDI	STRYKER ORTHOPAEDICS-MAHWAH		71731601

Patients

Seq	Age	Sex	Outcome	Treatment
1	65 YR		Required Intervention