UNKNOWN INSALL/BURSTEIN KNEE IMPLANT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,05,07 report with the FDA on 2015-04-17 for UNKNOWN INSALL/BURSTEIN KNEE IMPLANT manufactured by Zimmer Inc.

Event Text Entries

[5722632] It is reported that the patient was revised due to polyethylene wear and aseptic loosening at 22 years post - implant.
Patient Sequence No: 1, Text Type: D, B5

[13244492] Information was received via published literature. Please reference literature at the following location: http://jbjs. Org/content/96/18/e159. This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 1822565-2015-00567
• MDR Report Key: 4709908
• Report Source: 03,05,07
• Date Received: 2015-04-17
• Date of Report: 2015-03-17
• Date Mfgr Received: 2015-03-17
• Date Added to Maude: 2015-04-22
• 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: KEVIN ESCAPULE
• Manufacturer Street: P.O. BOX 708
• Manufacturer City: WARSAW IN 465810708
• Manufacturer Country: US
• Manufacturer Postal: 465810708
• Manufacturer Phone: 8006136131
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: UNKNOWN INSALL/BURSTEIN KNEE IMPLANT
• Generic Name: KNEE PROSTHESIS
• Product Code: HSA
• Date Received: 2015-04-17
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ZIMMER INC
• Manufacturer Address: P.O. BOX 708 WARSAW IN 46581070 US 46581 0708

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2015-04-17