MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HK TIBIAL BASE SZ 5 RIGHT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71421905
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a medical intervention was performed.Patient had right knee replacement of hinge joint put in.Patient has had severe pain for over 13 months with continues inflammation, continued severe knee pain, unable to bend (10-40 degrees) of the knee without severe pain; continued draining of synovial fluid with red blood cells in collection.Most draining consists of removing excess of 55 cc to 70 cc.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, the post revision x-rays provided demonstrate the hinge system in place but does not contribute to the root cause.Based on the limited information provided and without the return of the device for evaluation the root cause of the reported pain, inflammation, immobility, and fluid collection could not be concluded.However, the patient¿s comorbidities (ehlers-danlos syndrome and multiple ligament insufficiencies around his right knee) cannot be ruled out as contributing factors to the reported issues.Additionally, without the results of the knee aspirations we are unable to rule out an infection as a contributory factor.The patient impact beyond the reported issues cannot be determined.No further clinical assessment is warranted at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: LEGION HK TIBIAL BASE SZ 5 RIGHT
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8723515
• Report Number: 1020279-2019-02384
• Device Sequence Number: 1729876
• Product Code: KRO
• UDI-Device Identifier: 00885556108888
• UDI-Public: 00885556108888
• Combination Product (Y/N): N
• PMA/510(K) Number: K081111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2019

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 Expiration Date: 08/27/2023
• Device Catalogue Number: 71421905
• Device Lot Number: 13DBP0030
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 10/15/2019
• 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: PART# 71424026, LOT# 15MSM0344D.; PART# 71424026, LOT# 15MSM0344D
• Outcome Attributed to Adverse Event: Required Intervention