MAUDE Adverse Event Report: SMITH & NEPHEW, INC. KNEE-DUMMY IMPLANT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	74022213
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/01/1901
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient had bilateral surgery 8 years ago, and her rom is reduced.Pain and instability are alleged in both knees.Revision for the right knee was performed on (b)(6) 2019.Revision surgery for the left is not scheduled yet.
Additional Manufacturer Narrative
It was reported that a patient had bilateral tka 8 years ago.After that, it was noticed that her rom (range of motion) was reduced.Also, pain and instability were alleged in both knees.Revision for the right knee was performed and insert was exchanged.The associated device, used in treatment, was not returned for evaluation.Therefore the product analysis could not be performed.As device details were not made available, the device history record and complaint history cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Possible causes could include but not limited to size/alignment of device, surgical technique or joint laxity.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: KNEE-DUMMY IMPLANT
• 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: 9331792
• Report Number: 1020279-2019-04065
• Device Sequence Number: 2271947
• Product Code: JWH
• UDI-Device Identifier: 03596010554277
• UDI-Public: 03596010554277
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2020

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: 74022213
• Device Catalogue Number: UNKNOWN/UNREADABLE
• Device Lot Number: UNKNOWN/UNREADABLE
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 03/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1