MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY TIBIA BASE NP RT SZ 6; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74022216
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	12/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had a knee aspiration due to persistent pain and knee is turning black.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clincal/medical concluded, this case reports the patient complained of persistent knee pain with change in color ¿black¿ approximately 15 months post tka and x-ray images were obtained, on the lateral image it shows a radiolucency under the anterior femoral component where it was notched as well under the anterior tibial base plate, there is also radiolucency under the medial edge of the tibial base plate.There is a cyst-like finding posterior to the tibial base plate stem.Three months following the x-rays the patient underwent a knee aspiration documented under (b)(4).The following month the patient received the second knee aspiration documented under (b)(4).It was also communicated that the patient received knee injections documented under (b)(4).Neither the results of the knee aspirations or the dates of the knee injections were provided.Conclusion: based on the submitted xray images and limited information provided the root cause of the persistent knee pain cannot be concluded.Additionally, without the results of the knee aspirations we are unable to rule out an infection as a contributory factor.The reported color change may be related to hyperpigmentation which is a known phenomenon post cutaneous trauma/ injury (i.E.Surgical incisions, scrapes and any injury causing scarring or inflammatory response).The patient impact beyond the reported pain cannot be determined.No further medical investigation can be rendered at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: JOURNEY TIBIA BASE NP RT SZ 6
• 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: 8237417
• Report Number: 1020279-2019-00116
• Device Sequence Number: 18901220
• Product Code: JWH
• UDI-Device Identifier: 03596010554307
• UDI-Public: 03596010554307
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2019

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 Catalogue Number: 74022216
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 04/12/2019
• 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