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

Model Number	71421174
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	07/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after total knee replacement surgery had been performed on (b)(6) 2016, the implanted legion oxinium constrained femoral size 4 - right broke in half.This adverse event was treated by revision surgery completed on (b)(6) 2021.Current health status of patient is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation but the images provided were reviewed, and the fracture was confirmed.The clinical/medical investigation concluded that, based on the limited information provided the clinical root cause of the reported breakage could not be determined, however, we are unable to rule out the patient¿s body habitus of 301lbs as a contributing factor to the implant breakage.The future impact to the patient beyond the revision cannot be determined.Should additional information become available this issue can be re-elevated.No further clinical assessment is warranted at this time.A review of the complaint history for the listed part revealed no prior complaints for the listed failure.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 for this event could include but are not limited to abnormal loading of limb or excessive forces applied to implant or patient condition.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: LGN OX CONSTRAINED FEM 4 RT
• 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: 12304831
• Report Number: 1020279-2021-06286
• Device Sequence Number: 3971125
• Product Code: JWH
• UDI-Device Identifier: 03596010543905
• UDI-Public: 03596010543905
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71421174
• Device Catalogue Number: 71421174
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 09/10/2021
• 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
• Patient Weight: 137