MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHEM TIBIAL BASE PLATE SZ 4 RT; PROSTHESISKNEPATELOFEMOROTIBIALSMICONSTRAINDCMNTDPOLYMERMTALPOLYMER

Model Number	71422844
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Anemia (1706)
Date of Event	12/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a transfusion (prc) was performed since patient presented anemia.

• Brand Name: ANTHEM TIBIAL BASE PLATE SZ 4 RT
• Common Device Name: PROSTHESISKNEPATELOFEMOROTIBIALSMICONSTRAINDCMNTDPOLYMERMTALPOLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9875394
• Report Number: 1020279-2020-00997
• Device Sequence Number: 3041216
• Product Code: JWH
• UDI-Device Identifier: 00885556531471
• UDI-Public: 00885556531471
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K142807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2020

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: 71422844
• Device Catalogue Number: 71422844
• Device Lot Number: 18GM08576
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 03/24/2020
• Supplement Report FDA Received Date: 12/05/2020
• 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