MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHEM FEMORAL PS COCR SZ 5 RT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71422835
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/26/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a percutaneous inferior vena cava retrievable filter implantation was performed under local anesthesia due to deep venous thrombosis.
Additional Manufacturer Narrative
The associated complaint devices were not returned.According to clinical investigation, no further patient impact is anticipated and the issue was not related to the device or procedure.The event was reported as resolved and no further medical assessment is warranted at this time.Without the actual products involved, product evaluation could not be performed and our investigation cannot proceed.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incidents.A review of complaint history for the listed parts/lots revealed no prior complaints.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.If the devices or new information is received in the future, these complaints can be re-opened.No further actions are being taken at this time.
Additional Manufacturer Narrative
Additional information: d4 and h4.The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that all medical documents provided have been reviewed.No new medical information has been received since previous assessment.Therefore, the conclusion drawn in the previously completed medical investigation statement remain valid.Upon receipt of additional medical/clinical records, the clinical task will be re-opened and re-assessed at that time.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the instructions for use document revealed this failure mode was previously identified.Deep vein thrombosis is the probable cause of this event and is a complication associated with any surgery.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 devices or additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: ANTHEM FEMORAL PS COCR SZ 5 RT
• 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: 8914959
• Report Number: 1020279-2019-03101
• Device Sequence Number: 503105
• Product Code: JWH
• UDI-Device Identifier: 00885556531327
• UDI-Public: 00885556531327
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K142807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2020

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: 71422835
• Device Catalogue Number: 71422835
• Device Lot Number: 17GM08705
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 07/29/2019; 07/29/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 10/15/2019; 03/09/2020
• 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