MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION NARROW CR OXIN SZ 5 RT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71421245
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/23/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It has been reported that patient is suffering from complications following the implantation of prosthesis.No procedure reported to remediate adverse event.
Event or Problem Description
It has been reported that patient is suffering from complications following the implantation of prosthesis.No procedure reported to remediate adverse event.Update informs that the patient was diagnosed with algoneurodystrophy.After a fall on (b)(6) 2016, patient presented a fixed flexion of 100 degrees.Limited range of motion is considered final, no other specific additional therapy is proposed.
Additional Manufacturer Narrative
The associated legion cruciate retaining narrow oxinium femoral component was not returned for evaluation.As device details were made available, thus our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A clinical evaluation noted that scintigraphy confirmed the reported pain.However, without the requested clinical information, radiographs, lab reports, physical therapy records or the explant the root cause of the reported pain cannot be determined.Therefore, the information provided is insufficient to determine whether the patient¿s signs, symptoms, or outcomes are due to a pre-existing or concurrent medical or surgical condition or procedure, or to an adverse reaction with the device.In addition, the patient¿s trauma history as a contributing factor cannot be ruled out.It was reported that no additional therapy is required.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.
Additional Manufacturer Narrative
The associated legion cruciate retaining narrow oxinium femoral component was not returned for evaluation.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode nor with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A clinical evaluation noted that scintigraphy confirmed the reported pain.However, without the requested clinical information, radiographs, lab reports, physical therapy records or the explant the root cause of the reported pain cannot be determined.Therefore, the information provided is insufficient to determine whether the patient¿s signs, symptoms, or outcomes are due to a pre-existing or concurrent medical or surgical condition or procedure, or to an adverse reaction with the device.The surgeons selection of this device (oxidized zirconium) over other similar femoral components is most likely because of the low level of nickel content in the device.Oxinium material contains <0.0035% for detectable nickel, the leading cause of negative reactions in patients with metal sensitivities.It is so low that it could be considered "hypo-allergenic.In addition, the patient¿s trauma history as a contributing factor cannot be ruled out.No procedure has been reported to remediate the adverse event and there has been no additional therapy required.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened and reevaluated.

• Brand Name: LEGION NARROW CR OXIN 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: 8213634
• Report Number: 1020279-2019-00031
• Device Sequence Number: 16672146
• Product Code: JWH
• UDI-Device Identifier: 00885556233801
• UDI-Public: 00885556233801
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K112941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/09/2019

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: 10/27/2023
• Device Catalogue Number: 71421245
• Device Lot Number: 13KM21754
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/10/2018
• Supplement Date Received by Manufacturer: 12/10/2018; 12/10/2018; 12/10/2018
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 01/07/2019; 04/11/2019; 05/09/2019
• 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