FDA Adverse Event Injury Summary report: N

VNGD SSK PSC TIB BRG 22X71/75

MDR report key: 3904136 · Received July 1, 2014

Report

Report Number: 0001825034-2014-05829
Event Type: Injury
Date Received: July 1, 2014
Date of Event: June 18, 2012
Report Date: June 6, 2014
Manufacturer: BIOMET ORTHOPEDICS
Product Code: JWH
PMA / PMN Number: PK042757
Removal / Correction Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: PHYSICIAN

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. THIS REPORT IS NUMBER 6 OF 6 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05824 / 05829).

Description of Event or Problem · 1

IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY AND UNDERWENT A LEFT KNEE ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2011 DUE TO INFECTION AND THE KNEE COMPONENTS WERE REMOVED AND REPLACED WITH CEMENT SPACERS. PATIENT UNDERWENT A REIMPLANTATION PROCEDURE ON (B)(6) 2011. A SUBSEQUENT IRRIGATION AND DEBRIDEMENT PROCEDURE WAS PERFORMED ON (B)(6) 2011 DUE TO FORMATION OF A HEMATOMA. SUBSEQUENTLY, PATIENT UNDERWENT REVISION PROCEDURES ON (B)(6) 2012 AND (B)(6) 2012 FOR UNKNOWN REASONS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
382168	VNGD SSK PSC TIB BRG 22X71/75	PROSTHESIS, KNEE	JWH	BIOMET ORTHOPEDICS	N/A	552250

Patients

Seq	Age	Sex	Outcome	Treatment
1	48 YR		Hospitalization\| R