BIOLOX OR526969

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 2013-02-07 for BIOLOX OR526969 manufactured by Germany Manufacturing Site.

Event Text Entries

[15426964] It was reported that revision surgery was performed, due to breakage of the device.
Patient Sequence No: 1, Text Type: D, B5

[15747369] .
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 8010764-2013-00010
• MDR Report Key: 2949010
• Report Source: 07
• Date Received: 2013-02-07
• Date of Report: 2013-02-01
• Date of Event: 2013-01-16
• Date Mfgr Received: 2013-02-01
• Date Added to Maude: 2013-02-07
• 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: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: MRS. MELANIE TRAVIS
• Manufacturer Street: 1450 BROOKS ROAD
• Manufacturer City: MEMPHIS TN 38116
• Manufacturer Country: US
• Manufacturer Postal: 38116
• Manufacturer Phone: 9013996233
• Manufacturer G1: GERMANY MANUFACTURING SITE
• Manufacturer Street: ALEMANNENSTRASSSE 14
• Manufacturer City: TUTTLINGEN 78532
• Manufacturer Country: GM
• Manufacturer Postal Code: 78532
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BIOLOX
• Generic Name: FEMORAL COMPONENT
• Product Code: LPF
• Date Received: 2013-02-07
• Model Number: OR526969
• Catalog Number: OR526969
• Lot Number: UNKNOWN
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: GERMANY MANUFACTURING SITE
• Manufacturer Address: ALEMANNENSTRASSSE 14 TUTTLINGEN 78532 78532

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2013-02-07