PATELLA /KRP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-08-10 for PATELLA /KRP manufactured by Brooks Mfg Site.

Event Text Entries

[19461665] It has been reported that a revision surgery was performed due to disassociation of the patella.
Patient Sequence No: 1, Text Type: D, B5

[19709732] Na
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 1020279-2009-00654
• MDR Report Key: 1435727
• Report Source: 07
• Date Received: 2009-08-10
• Date of Report: 2009-08-10
• Date of Event: 2009-06-30
• Date Mfgr Received: 2009-07-10
• Date Added to Maude: 2009-08-13
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: MRS. LEAH EASLEY
• Manufacturer Street: 1450 BROOKS RD.
• Manufacturer City: MEMPHIS TN 38116
• Manufacturer Country: US
• Manufacturer Postal: 38116
• Manufacturer Phone: 9013996137
• Manufacturer G1: BROOK MFG SITE
• Manufacturer Street: 1450 BROOKS RD.
• Manufacturer City: MEMPHIS TN 38116
• Manufacturer Country: US
• Manufacturer Postal Code: 38116
• Single Use: 3
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: NI
• Generic Name: PATELLA /KRP
• Product Code: KRP
• Date Received: 2009-08-10
• Model Number: NA
• Catalog Number: NI
• Lot Number: NI
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BROOKS MFG SITE
• Manufacturer Address: MEMPHIS TN US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2009-08-10