FDA Adverse Event Other Summary report: N

FMP HIP

MDR report key: 2844959 · Received November 14, 2012

Report

Report Number: 1644408-2012-00606
Event Type: Other
Date Received: November 14, 2012
Date of Event: November 6, 2012
Report Date: November 6, 2012
Manufacturer: ENCORE MEDICAL, L.P.
Product Code: KWA
PMA / PMN Number: K003250
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 TO CONVERT FROM A BIPOLAR INTO A TOTAL HIP AFTER 2.3 MONTHS OF PATIENT USE. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE NON-SERIOUS. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS NOT RETURNED 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 SHOWS THIS IS THE 9TH COMPLAINT FOR THIS PART NUMBER: FOUR DUE TO DISLOCATION, ONE FOR STABILITY/POOR JOINT ISSUE, ONE PACKAGING CONTAMINATION CAUSED BY FLOODING, ONE DUE TO DEVICE LOOSENING, AND ONE REVISION/DUE TO LEG LENGTH. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE NEED OF THE CONVERSION WAS NOT IDENTIFIED OR REPORTED. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

Description of Event or Problem · 1

REVISION SURGERY - THE PT HAD A BIPOLAR CONVERTED TO A TOTAL HIP.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	FMP HIP	COCR HEAD -3.5	KWA	ENCORE MEDICAL, L.P.		A1000005

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR		Required Intervention	412-02-049, LOT 53990608