FDA Adverse Event Other Summary report: N

FOUNDATION HIP

MDR report key: 3180037 · Received June 13, 2013

Report

Report Number: 1644408-2013-00328
Event Type: Other
Date Received: June 13, 2013
Date of Event: June 5, 2013
Report Date: June 5, 2013
Manufacturer: ENCORE MEDICAL, L.P.
Product Code: KWY
PMA / PMN Number: K953510
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 REMEDY PAIN THE PATIENT WAS EXPERIENCING AFTER 10.6 YEARS OF PATIENT USE. THERE IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE REVISION SURGERY. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS KEPT BY THE HOSPITAL AND 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 FOURTH COMPLAINT FOR THIS PART NUMBER: ONE DUE TO WEAR/EXCESSIVE WEAR, ONE REVISION SURGERY, ONE DUE TO DISLOCATION, AND ONE FOR PAIN. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE PAIN WAS MOST LIKELY DUE TO NORMAL WEAR. 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 WAS REVISED DUE TO PAIN AND WEAR OF THE ACETABULUM. THE SURGEON REVISED TO A TOTAL HIP USING THE ORIGINAL HIP STEM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
270344	FOUNDATION HIP	SHELL, BIPOLOR HEMI	KWY	ENCORE MEDICAL, L.P.		780401

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR		Required Intervention	497-28-000, LOT 839021