MAUDE Adverse Event Report: MATERIALISE NV SIGNATURE; KNEE PROSTHESIS

Model Number	42-422551
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/14/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the internal documentation did not show an anomaly or deviation.The device met specification.A cause for this specific clinical event cannot be ascertained from the information provided.Should additional information become available and/or the device be returned for evaluation and an investigation result be available that changes this assessment, an amended medical device report will be filed.
Event or Problem Description
A patient specific guide was used to place a total knee replacement implant in (b)(6) 2013.Patient was revised due to malalignment of tibial and femoral components in (b)(6) 2017.

• Brand Name: SIGNATURE
• Common Device Name: KNEE PROSTHESIS
• Manufacturer (Section D): MATERIALISE NV; technologielaan 15; leuven, 3001 ; BE 3001
• MDR Report Key: 7062930
• Report Number: 3003998208-2017-00003
• Device Sequence Number: 1234922
• Product Code: JWH
• UDI-Device Identifier: E314424225510
• UDI-Public: E314424225510
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K102795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/19/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/10/2014
• Device Model Number: 42-422551
• Device Catalogue Number: 42-422551
• Device Lot Number: 087834
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2017
• Initial Report FDA Received Date: 11/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 100