MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION PS OXIN FEM SZ6 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71421216
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Fibrosis (3167)
Date of Event	08/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Event or Problem Description
It was reported that, after tkr surgery had been performed on (b)(6) 2018, the patient experienced arthrofibrosis, limited rom 15º-40º.This adverse event was solved by a revision surgery on (b)(6) 2021.Current health status of patient is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.The pictures provided were reviewed and could not confirm the stated failure mode.The clinical/medical investigation concluded that, based on the limited information provided, the clinical root cause of the reported issue of arthrofibrosis with limited rom could not be determined, however possible osteophyte/heterotopic ossification could not be ruled out as a contributing factor but cannot be confirmed as the images are undated and no comparison images were provided.Due to insufficient clinical information the patient impact beyond the reported symptoms and subsequent revision could not be determined.No further clinical/medical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes could be alignment, fit/size of device used or wear.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, 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.

• Brand Name: LEGION PS OXIN FEM SZ6 LT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12475044
• Report Number: 1020279-2021-06876
• Device Sequence Number: 3392509
• Product Code: JWH
• UDI-Device Identifier: 00885556030059
• UDI-Public: 00885556030059
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2021

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: 01/26/2026
• Device Model Number: 71421216
• Device Catalogue Number: 71421216
• Device Lot Number: 16AM19261
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 10/18/2021
• 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: 71421805/LGN POS FEM WDG 5MM SZ5-6 LNG; 71424165/LGN SHORT STEM EXT 14 X 80
• Outcome Attributed to Adverse Event: Hospitalization; Other