MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHEM TIBIAL BASE PLATE SIZE 3 RIGHT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71422843
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Anemia (1706)
Date of Event	12/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient suffered from anemia.The event was treated via transfusion and medication.
Additional Manufacturer Narrative
The devices, used treatment were not returned for evaluation, reporting event could not be confirmed.A clinical evaluation was conducted and confirms this complaint from south korea reports an episode of anemia which can be a complication of any surgery.Per the intake team; all efforts to obtain additional information regarding this complaint did not provide any results.Without supporting clinical/medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the risk management file and instructions for use document for this failure mode was conducted.Factors and/or some potential probable causes that could contribute to the reported event have been identified as age of patient, patient medical history, traumatic injury, and/or patient condition.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: ANTHEM TIBIAL BASE PLATE SIZE 3 RIGHT
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9739370
• Report Number: 1020279-2020-00668
• Device Sequence Number: 2475067
• 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: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2020

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: 19GM12568
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 07/30/2020
• 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
• Patient Age: 75 YR