FDA Adverse Event Other Summary report: N

X-ALT HIP

MDR report key: 2851071 · Received November 19, 2012

Report

Report Number: 1644408-2012-00615
Event Type: Other
Date Received: November 19, 2012
Date of Event: November 8, 2012
Report Date: November 8, 2012
Manufacturer: ENCORE MEDICAL, L.P.
Product Code: LPH
PMA / PMN Number: K072154
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE REASON FOR THIS REVISION SURGERY WAS TO REMEDY A HEMATOMA AFTER SEVEN DAYS OF PATIENT USE. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. 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 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 SECOND COMPLAINT FOR THIS PART NUMBER, ONE DUE TO DEVICE LOOSENING. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE HEMATOMA WAS NOT DETERMINED WITH CONFIDENCE. 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 HEMATOMA. THE SURGEON PERFORMED AN IRRIGATION AND DEBRIDEMENT AND CHANGED THE ACETABULAR LINER. THERE WAS NO IMPLANT FAILURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	X-ALT HIP	LINER/NON-HOODED-NEUTRAL MP11	LPH	ENCORE MEDICAL, L.P.		53982190

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention