MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION PS OXIN FEM SZ4 LT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71421214
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arthritis (1723)
Date of Event	08/27/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Study: legion primary with verilast study (12-4042-01); subject: 70-002; ae#02: it was reported that after a legion ps oxinium system had been implanted.The subjects experienced worsening of retropatellar arthritis.This adverse events were treated with surgery.
Additional Manufacturer Narrative
D6(a): added implantation date.H10: the date of initial implantation was (b)(6) 2018 and.None of the devices were explanted during the revision for retro patellar replacement performed on (b)(6) 2020.Based on the findings in the revision report the retro patellar replacement was not a part of the initial tka procedure.The surgical report states, ¿this shows a pronounced retro patellar arthrosis with large cartilage baldness and considerable pannus attachments.Deformation of the lateral patella pole.Thus, correct indication for the implantation of a retro patellar replacement.¿ as mentioned in the revision operative report ¿the implants are fit and absolutely stable,¿ there is no indication of removal for the femoral component, the tibial insert component, or the tibial base component.
Additional Manufacturer Narrative
D4, h6.The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that based on the information provided the reason for the revision was for retropatellar osteoarthritis which could be progression of prior disease and not a mal-performance of the s&n device.The future impact to the patient beyond the revision cannot be determined.Should additional information becomes available this issue can be re-elevated.No further clinical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed batch.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 risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, patient reaction or loss of sterility.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
Additional Manufacturer Narrative
Section b4 was updated due to new information received.
Event or Problem Description
It was reported that after a tka performed on october 31, 2018 where a legion ps oxinium system had been implanted due to knee osteoarthritis, patellofemoral hypercompression syndrome and retropatellar osteoarthritis.The patient experienced no relief of symptoms and experienced worsening retropatellar arthritis with large cartilage glaces and considerable pannus deposits.The patient underwent an additional surgery on (b)(6) 2020, where a patellofemoral replacement was performed.The patient's outcome is unknown.

• Brand Name: LEGION PS OXIN FEM SZ4 LT
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 1450 brooks road; memphis, TN 38116 ; 5123913905
• MDR Report Key: 11616759
• Report Number: 1020279-2021-02683
• Device Sequence Number: 3397210
• Product Code: JWH
• UDI-Device Identifier: 00885556029121
• UDI-Public: 00885556029121
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/31/2022

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: 71421214
• Device Catalogue Number: 71421214
• Device Lot Number: 18DM22925
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 07/01/2021; 08/24/2021; 03/18/2022
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 07/01/2021; 08/24/2021; 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Sex: Unknown