FDA Adverse Event Injury Summary report: N

FMP HIP

MDR report key: 3813609 · Received May 15, 2014

Report

Report Number: 1644408-2014-00300
Event Type: Injury
Date Received: May 15, 2014
Date of Event: May 8, 2014
Report Date: May 8, 2014
Manufacturer: ENCORE MEDICAL, L.P.
Product Code: KWA
PMA / PMN Number: K040354
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE REASON FOR THIS REVISION SURGERY WAS REPORTED AS INSTABILITY AFTER 55 DAYS OF PATIENT USE. THERE IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE NEED FOR REVISION. THE HEALTHCARE PROFESSIONAL INDICATED A SIGNIFICANT ADVERSE EVENT TO THE PATIENT. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS DISPOSED OF AT THE HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWED THIS IS THE FIRST COMPLAINT FROM THIS LOT. THE ROOT CAUSE FOR THE INSTABILITY COULD NOT BE DETERMINED WITH CONFIDENCE. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

Description of Event or Problem · 1

REVISION SURGERY - DUE TO THE HIP STEM HAVING SUBSIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
291116	FMP HIP	COCR HEAD 36MM	KWA	ENCORE MEDICAL, L.P.		638C1099

Patients

Seq	Age	Sex	Outcome	Treatment
1	88 YR		Other\| R	(B)(4), LOT 931B1052