MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN OX CONSTRAINED FEM 4 RT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POL/M/POL

Model Number	71420523
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	09/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka had been performed on (b)(6) 2016, the patient had stiffness.A revision surgery was performed to washout and debride the knee.An increase in range of motion was achieved; nonetheless, scar tissue formed again after surgery.
Additional Manufacturer Narrative
It was reported that the patient underwent a first revision of tka in 2016 due to knee stiffness.Approximately, a month ago, a washout and debridement were performed due to stiffness with good effect (increased range of motion).The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.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.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 risk management files and the instructions for use found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.Some potential causes of the reported event could include but are not limited to surgical technique or post-operative healing issue.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: LGN OX CONSTRAINED FEM 4 RT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POL/M/POL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10603880
• Report Number: 1020279-2020-04935
• Device Sequence Number: 2940829
• Product Code: JWH
• UDI-Device Identifier: 03596010555823
• UDI-Public: 03596010555823
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2021

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: 01/25/2026
• Device Model Number: 71420523
• Device Catalogue Number: 71421174
• Device Lot Number: 16AM18908
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 02/16/2021
• 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: (B)(4), LN: 11DAP2764A; (B)(4), LN: 15KSM0270C; (B)(4), LN: 16DM00300; (B)(4), LN: 16ESM0306A; (B)(4), LN: 16FM21606; (B)(4), LN: 11DAP2764A; (B)(4), LN: 15KSM0270C; (B)(4), LN: 16DM00300; (B)(4), LN: 16ESM0306A; (B)(4), LN: 16FM21606
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 78 YR