MAUDE Adverse Event Report: BREG, INC. BIOMET KNEE SLEEVE OPEN PATELLA

Model Number 130615

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Laceration(s) (1946); Pain (1994); Swelling (2091); Thrombosis (2100)

Event Date 12/25/2013

Event Type  Injury  

Event Description

Patient alleges he developed a left lower extremity deep vein thrombosis (lle dvt) from use of product.No report of product malfunction.The patient tore his lateral meniscus of l knee in early (b)(6).On (b)(6) 201,3 the patient was injected cortisone in the knee and also placed his lle in a flexible knee brace.He did well until (b)(6) 2013 when he awakened with sudden onset of a swollen l ankle and painful l calf.Patient was hospitalized overnight, placed on anticoagulant treatment and released.

Manufacturer Narrative

Product was inspected upon receipt.Brace appeared to be moderately used and in good condition.No evidence of malfunction or defect.

• Brand Name: BIOMET KNEE SLEEVE OPEN PATELLA
• Type of Device: KNEE SLEEVE OPEN PATELLA
• Manufacturer (Section D): BREG, INC.; 2885 loker avenue east; carlsbad CA 92010
• Manufacturer (Section G): BREG, INC.; 2885 loker avenue east; carlsbad CA 92010
• Manufacturer Contact: carol emerson ; 2885 loker avenue east; carlsbad, CA 92010 ; 7607955823
• MDR Report Key: 3784749
• MDR Text Key: 4440610
• Report Number: 2028253-2014-00009
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 130615
• Device Catalogue Number: 130615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/04/2014
• Initial Date FDA Received: 05/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR