MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHEM FEMORAL CR COCR SZ 5 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	71422935
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	10/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Event or Problem Description
Anthem cr study (17 4065 07); subject: 20 013; ae: 08: dvt in lt.Calf vein.It was reported that, after an anthem tka surgery performed on 30 sep 2019, the patient experienced deep vein thrombosis (dvt) in the calf vein.This was treated by taking eliquis from 03 oct 2019 to 29 dec 2019.This condition was resolved on 18 feb 2020.
Additional Manufacturer Narrative
The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, based on the information provided, this adverse event was resolved two months after the completion of the eliquis.Since no other harm has been alleged to this patient, no further clinical/medical assessment is warranted at this time.Should any additional relevant medical information be provided, this case would be re-assessed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review of the instructions for use for this device revealed that wound hematoma, thromboembolic diseases including venous thrombosis, pulmonary embolus, or myocardial infarction.Have been identified in possible adverse effects.A historical review concluded that there are no prior actions related to this product and event.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/user error, surgical complication or patient condition.The contribution of the device to the reported event could not be corroborated.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.
Additional Manufacturer Narrative
H10: h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, based on the information provided, this adverse event was resolved two months after the completion of the eliquis.Since no other harm has been alleged to this patient, no further clinical/medical assessment is warranted at this time.Should any additional relevant medical information be provided, this case would be re-assessed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review of the instructions for use for this device revealed that wound hematoma, thromboembolic diseases including venous thrombosis, pulmonary embolus, or myocardial infarction.Have been identified in possible adverse effects.A historical review concluded that there are no prior actions related to this product and event.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/user error, surgical complication or patient condition.The contribution of the device to the reported event could not be corroborated.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 5 LT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14671963
• Report Number: 1020279-2022-02961
• Device Sequence Number: 17436320
• Product Code: JWH
• UDI-Device Identifier: 00885556655801
• UDI-Public: 00885556655801
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K170648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71422935
• Device Catalogue Number: 71422935
• Device Lot Number: 17KM02474
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2022
• Supplement Date Received by Manufacturer: 07/22/2022; 07/29/2022
• Initial Report FDA Received Date: 06/11/2022
• Supplement Report FDA Received Date: 07/27/2022; 08/07/2022
• Date Device Manufactured: 10/03/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71422693; 71422966
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 68 KG