FDA Adverse Event Injury Summary report: N

DEPUY INC.

MDR report key: 519095 · Received January 7, 2004

Report

Report Number: MW1031629
Event Type: Injury
Date Received: January 7, 2004
Date of Event: March 18, 2003
Report Date: January 7, 2004
Manufacturer: DEPUY INC.
Product Code: HSN
Product Problem: Yes
Report Source: Voluntary report
Reporter Location: SD, US
Reporter Occupation: NURSE

Narratives

Description of Event or Problem · 1

PT ADMITTED WITH A DIAGNOSIS OF FAILED RIGHT TOTAL ANKLE ARTHROPLASTY WITH PROBABLE FRACTURE OF THE TALUS WITH LARGE CYSTIC LESIONS IN THE TALUS AND SUBTALAR JOINT.

Description of Event or Problem · 1

ADD'L INFO REC'D FROM MFR 05/18/04: THE TOTAL IMPLANT DURATION TIME FOR THE DEVICE WAS APPROX FOUR YEARS AND FIVE MONTHS. DEPUY'S MEDWATCH REPORT NUMBER FOR THIS EVENT IS 1818910-2004-00078. THE INITIAL REPORT WAS SUBMITTED ON FEBRUARY 11, 2004 AND A FOLLOW-UP REPORT WAS SENT ON MARCH 9, 2004. THIS REPORT RELATES TO PRODUCT CODE 1555-04-000. NO MEDWATCH WAS SUBMITTED FOR PRODUCT CODE 1555-34-000, AS THE POTENTIAL FOR PRODUCT CAUSE OR CONTRIBUTION TO THE NEED FOR REVISION SURGERY WAS NOT ESTABLISHED FOR THIS PRODUCT. ALSO, PLEASE NOTE THAT THE REPORTS ATTACHED TO LETTER SEEM TO HAVE INCORRECTLY ASSOCIATED THE LOT NUMBERS WITH THE PROUDCT CODES FOR THE TWO DEVICES. THE ATTACHED REPORTS SHOW "CATALOG" 1555-34-000 WITH "LOT" ST4HL1005, AND "CATALOG" 1555-04 WITH "LOT" S21FW1010. THE ACTUAL PRODUCT/LOT COMBINATIONS (WITH PRODUCT DESCRIPTIONS) ARE SHOWN BELOW. 1555-04-000, ST4HL1005, AGILITY TALAR ANKLE, SZ 4, COBALT CHROME. 1555-34-000, S21FW1010, AGILITY ANKLE INSERT, SZ 4, POLYETHYLENE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	DEPUY INC.	AGILITY TALAR/TIBIAL ANKLE	HSN	DEPUY INC.	*	ST4HL1005
2	DEPUY INC.	AGILITY TALAR/TIBIAL ANKLE	HSN	DEPUY INC.	*	S21FW1010

Patients

Seq	Age	Sex	Outcome	Treatment
1	59 YR		Required Intervention