FDA Adverse Event Injury Summary report: N

SERIES A PAT THN 34 3 PEG

MDR report key: 3904137 · Received July 1, 2014

Report

Report Number: 0001825034-2014-05826
Event Type: Injury
Date Received: July 1, 2014
Date of Event: January 3, 2011
Report Date: June 6, 2014
Manufacturer: BIOMET ORTHOPEDICS
Product Code: JWH
PMA / PMN Number: PK040770
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. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH (B)(4). THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, ¿EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION.¿ THIS REPORT IS NUMBER 3 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
382886	SERIES A PAT THN 34 3 PEG	PROSTHESIS, KNEE	JWH	BIOMET ORTHOPEDICS	N/A	412770

Patients

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