MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION CR OXIN FEM SZ4 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71421234
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after tka surgery had been performed on unknown date, the patient had a revision surgery on (b)(6) 2021 because the femur was placed in an incorrect valgus of +12 degrees.The current health status of the patient is unknown.
Additional Manufacturer Narrative
H3, 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, per the complaint details, we are currently unable to rule out a procedural variance as a contributing factor to the reported event which does not represent a device malfunction.Based on the information provided the patient had a revision because the femur was placed in an incorrect valgus of +12 degrees.The impact to the patient beyond that which has already been reported cannot be determined.Should any additional medical information be provided, this complaint will be re-assessed.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.Possible causes could include but not limited to surgical technique used, size of device or user/procedural variance.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 CR OXIN FEM SZ4 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: 12173276
• Report Number: 1020279-2021-05992
• Device Sequence Number: 16378049
• Product Code: JWH
• UDI-Device Identifier: 00885556030912
• UDI-Public: 00885556030912
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2021

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 Expiration Date: 06/14/2025
• Device Model Number: 71421234
• Device Catalogue Number: 71421234
• Device Lot Number: 15FM12792G
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 08/25/2021
• 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 Age: 62 YR
• Patient Weight: 112