FDA Adverse Event Injury Summary report: N

APEX KNEE SYSTEM

MDR report key: 12369816 · Received August 26, 2021

Report

Report Number: 1226188-2021-00104
Event Type: Injury
Date Received: August 26, 2021
Date of Event: August 9, 2021
Report Date: August 26, 2021
Manufacturer: OMNI LIFE SCIENCE
Product Code: JWH
UDI-DI: 00841690101963
PMA / PMN Number: K060192
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: UT, US
Reporter Occupation: 003

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) 2021. THE ORIGINAL SURGERY IS DATE (B)(6) 2020. THE REVISION SURGERY OCCURRED BECAUSE OF A LOOSE PATELLA. DURING THE REVISION, THE PATELLA IMPLANT, TIBIAL INSERT AND BOLT WERE REMOVED AND REPLACED WITH A NEW COMPONENTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1266396	APEX KNEE SYSTEM	PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL	JWH	OMNI LIFE SCIENCE	KC-40350	35009	00841690101963

Patients

Seq	Age	Sex	Outcome	Treatment
1	38 YR		Hospitalization\| R