FDA Adverse Event Injury Summary report: N

PROFEMUR(R) HIP STEM

MDR report key: 1752042 · Received July 10, 2010

Report

Report Number: 1043534-2010-00264
Event Type: Injury
Date Received: July 10, 2010
Report Date: October 25, 2011
Manufacturer: WRIGHT MEDICAL TECHNOLOGY, INC.
Product Code: LPH
PMA / PMN Number: K060358
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FI
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION RECEIVED (B)(6) 2011: PATIENT IDENTIFIER - (B)(6); PATIENT WEIGHT - (B)(6); CATALOG LOT NUMBER - PHA0-1224, (B)(4); ORIGINAL SURGERY DATE (B)(6) 2008, REVISION SURGERY (B)(6) 2010; MANUFACTURE DATE - 09.08.2007. CORRECTED INFORMATION RECEIVED (B)(6) 2011: 510K SUBMISSION NUMBER - K060358. THIS IS THE SAME EVENT AS 1043534-2010-00263, 00265. THIS EVENT OCCURRED IN (B)(6).

Additional Manufacturer Narrative · 1

CONCLUSION: NO CONCLUSION CAN BE DRAWN. PRODUCT NOT RETURNED. COMPLAINT HISTORY REVIEWED. PRODUCT CONFORMANCE COULD NOT BE DETERMINED. USE OF DEVICE COULD NOT BE DETERMINED.

Additional Manufacturer Narrative · 1

INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. NO COMPLAINT WAS STATED AGAINST THIS DEVICE. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2010-00263, 00265. THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem · 1

ALLEGEDLY THE COMPONENT WAS REMOVED DURING REVISION SURGERY OF ANOTHER COMPONENT.

Description of Event or Problem · 1

ALLEGEDLY THE COMPONENT WAS REMOVED DURING REVISION SURGERY OF ANOTHER COMPONENT.

Description of Event or Problem · 1

ALLEGEDLY THE COMPONENT WAS REMOVED DURING REVISION SURGERY OF ANOTHER COMPONENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PROFEMUR(R) HIP STEM	HIP COMPONENT	LPH	WRIGHT MEDICAL TECHNOLOGY, INC.		027405751

Patients

Seq	Age	Sex	Outcome	Treatment
1	66 YR		Hospitalization\| R