MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHEM TIBIAL BASE PLATE SIZE 3 RIGHT; PROSTHESISKNEEPATELLOFEMOROTIBIALSEMICONSTRAINEDCMNTDPOLYMERMETALPOLYMER

Model Number	71422843
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/25/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) clinical study (b)(6).Subject: (b)(6).Ae#02: it was reported that patient underwent knee manipulation to resolve a rom limitation issue.
Additional Manufacturer Narrative
The information received by the manufacturer has been re-evaluated for mdr reporting.The information states that event did not occur, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: ANTHEM TIBIAL BASE PLATE SIZE 3 RIGHT
• Common Device Name: PROSTHESISKNEEPATELLOFEMOROTIBIALSEMICONSTRAINEDCMNTDPOLYMERMETALPOLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9557482
• Report Number: 1020279-2020-00127
• Device Sequence Number: 2300127
• Product Code: JWH
• UDI-Device Identifier: 00885556531464
• UDI-Public: 00885556531464
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K142807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

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 Model Number: 71422843
• Device Catalogue Number: 71422843
• Device Lot Number: 19GM04103
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 03/03/2020
• 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: Hospitalization; Required Intervention