FDA Adverse Event Injury Summary report: N

OMNI HIP SYSTEM

MDR report key: 7817828 · Received August 27, 2018

Report

Report Number: 1226188-2018-00057
Event Type: Injury
Date Received: August 27, 2018
Date of Event: April 10, 2018
Report Date: May 3, 2018
Manufacturer: OMNILIFE SCIENCE, INC.
Product Code: LPH
UDI-DI: 00841690119869
PMA / PMN Number: K073150
Adverse Event: Yes
Report Source: Manufacturer report
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 HIP REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2014. THE REVISION SURGERY OCCURRED BECAUSE OF REPORTED INSTABILITY. DURING THE REVISION, THE ORIGINAL OMNI 36MM ID X 0 DEGREE HOOD ACETABULAR INSERT WAS REMOVED AND REPLACED WITH A 36MM ID X 10° HOOD ACETABULAR INSERT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
661008	OMNI HIP SYSTEM	PROSTHESIS, HIP, SEMI-CONSTRAINED	LPH	OMNILIFE SCIENCE, INC.		16259	00841690119869

Patients

Seq	Age	Sex	Outcome	Treatment
1	23 YR		Hospitalization\| R