FDA Adverse Event Injury Summary report: N

N-K II NONPOROUS REVISION FEMORAL COMPONENT

MDR report key: 3820017 · Received May 14, 2014

Report

Report Number: 1822565-2014-00615
Event Type: Injury
Date Received: May 14, 2014
Report Date: April 19, 2014
Manufacturer: ZIMMER INC
Product Code: JWH
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

COMPATIBILITY WAS VERIFIED WITH NO ISSUES NOTED. OPERATIVE NOTES INDICATE A TRIAL REDUCTION PROVIDED GOOD STABILITY WITH GOOD EXTENSION. THE CEMENT WAS ALLOWED TO CURE WITH THE KNEE IN FULL EXTENSION. REVIEW OF THE OPERATIVE NOTES DOES NOT INDICATE ROOT CAUSE. A THREE PHASE BONE SCAN WAS PERFORMED AND INDICATED FEMORAL AND TIBIAL LOOSENING RADIOGRAPHS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. HOWEVER, THE COMPLAINT MAY BE REVISED UPON RETURN OF RADIOGRAPHS AND/OR PRODUCT OR FURTHER INFORMATION. DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM.

Description of Event or Problem · 1

IT IS REPORTED THAT THE PT IS EXPERIENCING IMPLANT LOOSENING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
288736	N-K II NONPOROUS REVISION FEMORAL COMPONENT		JWH	ZIMMER INC		0788035

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other	AND DISTRIBUTED THROUGH (B)(4)\| CATALOG #00111314001, LOT #63153901 - THIS BONE\| PALACOS R+G BONE CEMENT,\| CEMENT IS MANUFACTURED AT HERAEUS MEDICAL\| N-K II CONSTRAINED TIBIAL BASEPLATE,\| CATALOG #632414100, LOT #1617925\| (B)(4).