FDA Adverse Event Injury Summary report: N

E1 VNGD PS+ TIB BRG 71/75X16

MDR report key: 5399684 · Received January 29, 2016

Report

Report Number: 0001825034-2016-00295
Event Type: Injury
Date Received: January 29, 2016
Report Date: January 11, 2016
Manufacturer: BIOMET ORTHOPEDICS
Product Code: JWH
PMA / PMN Number: PK080528
Removal / Correction Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. DATE EXPLANTED - REMAINS IMPLANTED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2015-05178-1 / 2015-05179-1 / 2015-05180-1 / 2016-00295).

Description of Event or Problem · 1

IT WAS REPORTED THAT PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2014. PATIENT EXPERIENCED A QUAD MUSCLE TEAR EIGHT WEEKS POST OP; HOWEVER, THE EVENT WAS NOT RELATED TO IMPLANTS. PATIENT UNDERWENT A PROCEDURE TO REPAIR THE TEAR. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 DUE TO INSTABILITY. THE BEARING WAS REMOVED AND REPLACED. PATIENT REPORTS EXPERIENCING PAIN AND DRAINING FLUID. NO FURTHER INFORMATION HAS BEEN PROVIDED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
56938	E1 VNGD PS+ TIB BRG 71/75X16	PROSTHESIS, KNEE	JWH	BIOMET ORTHOPEDICS	N/A	086050

Patients

Seq	Age	Sex	Outcome	Treatment
1	57 YR		Hospitalization\| R