MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHEM TIBIAL BASE PLATE SZ 5 LT; PROSTHESISKNEPATELOFMOROTIBIALSMICONSTRAINDCMNTDPOLYMRMETALPOLYMER

Model Number	71422695
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/25/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that transfusions (pc) were performed on july 25th and on august 8th due to a worsening thrombocytopenia.

• Brand Name: ANTHEM TIBIAL BASE PLATE SZ 5 LT
• Common Device Name: PROSTHESISKNEPATELOFMOROTIBIALSMICONSTRAINDCMNTDPOLYMRMETALPOLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9875934
• Report Number: 1020279-2020-01007
• Device Sequence Number: 2877501
• Product Code: JWH
• UDI-Device Identifier: 00885556531402
• UDI-Public: 00885556531402
• 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: foreign,health professional,u
• 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: 71422695
• Device Catalogue Number: 71422695
• Device Lot Number: 18LM00420
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2020
• Supplement Date Received by Manufacturer: 11/26/2020
• 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