FDA Adverse Event Injury Summary report: N

11MM/130 DEG TI CANN TFNA 360MM/LEFT - STERILE

MDR report key: 5519506 · Received March 23, 2016

Report

Report Number: 1719045-2016-10247
Event Type: Injury
Date Received: March 23, 2016
Report Date: March 2, 2016
Manufacturer: SYNTHES MONUMENT
Product Code: HSB
PMA / PMN Number: PK131548
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NV, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(6). (B)(4). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). PART NUMBER: 04.037.157S, LOT NUMBER: 7951448, RAW MATERIAL NUMBER: (B)(4): MANUFACTURE DATE: APRIL 13, 2015. EXPIRATION DATE: FEBRUARY 28, 2025. A REVIEW OF DEPUY SYNTHES (B)(4) DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO ISSUES FOR THIS COMPLAINT NUMBER NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem · 1

IT WAS REPORTED THAT ORIGINAL PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE. POST-OPERATIVELY DUE TO REPORTED PAIN, FEMORAL NECK WAS SHORTENED AND WAS IN VARUS, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2016 TO EXPLANT A NAIL AND A BLADE. THERE WERE NO SURGICAL DELAYS REPORTED, PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT WAS REVISED WITH A TOTAL HIP. NO ALLEGATIONS AGAINST IMPLANTS WERE REPORTED. THIS IS REPORT 1 OF 2 FOR (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
175014	11MM/130 DEG TI CANN TFNA 360MM/LEFT - STERILE	ROD, FIXATION, INTRAMEDULLARY	HSB	SYNTHES MONUMENT		7951448

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention