MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHEM FEMORAL CR COCR SZ 3 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/

Model Number	71422933
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Cardiovascular Dysfunction/Insufficiency (4445)
Date of Event	08/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference number: case(b)(4).
Event or Problem Description
It was reported that after bilateral tka the patient developed deep vein thrombosis on the left side.The event was treated via medication.The patient status is currently unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, this clinical study case reports that following a bilateral tka the patient developed a left calf dvt.Per the provided documentation, this adverse event is unrelated to the study procedure.The patient was put on medication therapy, and the outcome is reported as resolved.No further medical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A complaint history review found related failures for the listed batch; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to procedural error, surgical complication, overuse or excessive pressure on the joint, injury and/or patient condition or medical history.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: ANTHEM FEMORAL CR COCR SZ 3 LT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11479269
• Report Number: 1020279-2021-02130
• Device Sequence Number: 3625293
• Product Code: JWH
• UDI-Device Identifier: 00885556655788
• UDI-Public: 00885556655788
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K170648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2021

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: 71422933
• Device Catalogue Number: 71422933
• Device Lot Number: 17JM07687
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71422692/ANTHEM TIBIAL BASE PLATE SZ 2 LT/19DM1397; 71422961/ANTHEM CR HF INSERT SZ 1-2 9MM/19GM08830; 71422692/ANTHEM TIBIAL BASE PLATE SZ 2 LT/19DM1397; 71422961/ANTHEM CR HF INSERT SZ 1-2 9MM/19GM08830
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention