FDA Adverse Event Injury Summary report: N

FMP HIP

MDR report key: 3874214 · Received June 16, 2014

Report

Report Number: 1644408-2014-00370
Event Type: Injury
Date Received: June 16, 2014
Date of Event: April 18, 2014
Report Date: June 10, 2014
Manufacturer: ENCORE MEDICAL, L.P.
Product Code: LPH
PMA / PMN Number: K974093
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 REPORTED AS DEVICE LOOSENING AFTER 10.2 YEARS OF PATIENT USE. 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 FOR THIS PART NUMBER FROM THIS LOT. THE ROOT CAUSE FOR THE DEVICE LOOSENING WAS REPORTED AS A FALL. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT.

Description of Event or Problem · 1

REVISION SURGERY - DUE TO A FALL, THE ACETABULAR CUP WAS LOOSE. THE SURGEON REMOVED THE ACETABULAR COMPONENTS AND REIMPLANTED THE BIOMET ACETABULAR SHELL AND LINER. THE FEMORAL COMPONENT WAS FIXED BUT THE SURGEON REMOVED THE FEMORAL HEAD AND REPLACED IT WITH A NEW 36MM FEMORAL HEAD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
352796	FMP HIP	FMP HEMISPHERICAL SHELL, 3 SCREWHOLE CLUSTER 52MM	LPH	ENCORE MEDICAL, L.P.		938531

Patients

Seq	Age	Sex	Outcome	Treatment
1	85 YR		Other\| R	010-55-035,LOT 844371\| 433-28-207,LOT 937891\| 497-28-700,LOT 697421