FDA Adverse Event Injury Summary report: N

DEPUY MITEK

MDR report key: 2465582 · Received February 17, 2012

Report

Report Number
MW5024291
Event Type
Injury
Date Received
February 17, 2012
Date of Event
July 16, 2011
Report Date
February 12, 2012
Manufacturer
DEPUY MITEK, INC.
Product Code
MAI
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
NC, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

AREA OF GROOVING ON FEMORAL CONDYLE AND A CORRESPONDING AREA ON THE TIBIAL SIDE. INFLAMMATION AND SYNOVIUM PROLONGED PAIN AND DYSFUNCTION IN KNEE JOINT. REASON FOR USE: MENISCAL REPAIR.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 DEPUY MITEK RAPID LOC MENISCAL REPAIR-PLA TOPHAT/27 DEGREES MAI DEPUY MITEK, INC. 0702211

Patients

Seq Age Sex Outcome Treatment
1 31 YR Required Intervention| S