FDA Adverse Event Injury Summary report: N

APEX KNEE SYSTEM

MDR report key: 6086561 · Received November 8, 2016

Report

Report Number: 1226188-2016-00091
Event Type: Injury
Date Received: November 8, 2016
Date of Event: October 12, 2016
Report Date: October 12, 2016
Manufacturer: OMNILIFE SCIENCE, INC.
Product Code: JWH
PMA / PMN Number: K060192
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OK, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE COMPLAINANT MADE NO INDICATION OF ANY OMNILIFE SCIENCE DEVICE MALFUNCTION OR DEFICIENCY RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS OR DEVICE PERFORMANCE CONTRIBUTING TO THE ADVERSE EVENT. REVIEW OF THE MANUFACTURING DOCUMENTATION AND STERILIZATION DOCUMENTATION FOR THE DEVICES IN QUESTION REVEALED NO DEVIATION FROM PROCESS OR NON-CONFORMITY OF PRODUCT THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT.

Description of Event or Problem · 1

THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2016. THE ORIGINAL SURGERY IS DATED (B)(6) 2016. THE REVISION SURGERY OCCURRED BECAUSE OF INFECTION. DURING THE REVISION, THE ORIGINAL OMNI FEMORAL COMPONENT, TIBIAL BASEPLATE, TIBIAL INSET AND RETAINING BOLT WERE REPLACED WITH NEW COMPONENTS. THE ORIGINAL SIZE 4 FEMORAL COMPONENT WAS REVISED TO A SIZE 3+, THE STANDARD TIBIAL BASEPLATE WAS REVISED TO A MODULAR TIBIAL BASEPLATE, THE 4 X 10MM ULTRA INSERT WAS REVISED TO A 3 X 14MM PS-C INSERT AND THE RETAINING BOLT WAS REVISED TO A NEW COMPONENT. IN ADDITION TO THE REVISED COMPONENTS, A PATELLA, TWO MODULAR OFFSET STEMS AND TWO TIBIAL PEGS WERE ADDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
736582	APEX KNEE SYSTEM	PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL	JWH	OMNILIFE SCIENCE, INC.		23076

Patients

Seq	Age	Sex	Outcome	Treatment
1	62 YR		Hospitalization\| R