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

Model Number	71422953
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	08/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, three days after tka surgery had been performed with anthem femoral cr cocr sz 3 rt on (b)(6) 2019, the clinical subject experienced a deep vein thrombosis (dvt) which was initially assessed as unrelated to either study device or study procedure.This adverse event was treated by medication (eliquis) on (b)(6) 2019.On 13-07-2021 it was clarified that the event was caused by the study procedure.Current health status of the clinical subject is recovered.
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 reported three days post-op surgery with the anthem femoral cr cocr sz 3 rt; adverse event #04 dvt occurred.This complaint was initially classified as unrelated to either the study device or the study procedure.However, since the occurrence of a deep vein thrombosis (dvt), is a known complication of surgery, the classification of this compliant was clarified; adverse event #04 dvt, was caused by the study procedure.According to the report, adverse event #04, was treated with a medication for blood clots (eliquis).The attached clinical record forms were reviewed and provided insight into the reported issue.Based on the information provided, this adverse event was reported as resolved; therefore, no further clinical/medical assessment is warranted at this time.Should any relevant supporting documentation be provided, this complaint would be re-assessed.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Some potential probable causes for this event could include but not limited to procedural error, surgical complication, overuse and/or excessive pressure on the joint.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 RT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12236159
• Report Number: 1020279-2021-06061
• Device Sequence Number: 17052705
• Product Code: JWH
• UDI-Device Identifier: 00885556655900
• UDI-Public: 00885556655900
• Combination Product (Y/N): N
• PMA/510(K) Number: K170648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2021

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: 71422953
• Device Catalogue Number: 71422953
• Device Lot Number: 17DM04630
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/13/2021
• Supplement Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 09/21/2021
• 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: Other
• Patient Age: 67 YR