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

Model Number	71422933
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, after tka surgery had been performed with anthem femoral cr cocr sz 3 lt on (b)(6) 2019, 10 days later 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 (cuoxane) on (b)(6) 2019.On 13-07-2021 the site had clarified that the event was caused by the study procedure, at which point the event was classified as serious adverse device effect (sade).Current health status of the clinical subject is recovered.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, after three requests it was reported no further information will be provided.The crfs provided were reviewed.According to the complaint, the clinical study subject dvt was caused by the study procedure and classified as a sade.It was reported the adverse event was treated with medication.Since the patient¿s current health status has been reported as recovered, no further clinical/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/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12235997
• Report Number: 1020279-2021-06052
• Device Sequence Number: 14361286
• Product Code: JWH
• UDI-Device Identifier: 00885556655788
• UDI-Public: 00885556655788
• 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): 09/09/2021

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: 07/13/2021
• Supplement Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 09/09/2021
• 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: CUOXANE; CUOXANE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR