MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION CR OXIN FEM SZ3 RT; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL/POLY

Catalog Number	71421223
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/28/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a right knee revision surgery was performed due to loosening.
Additional Manufacturer Narrative
Results: the associated devices were not returned for evaluation.The patient underwent a right tka revision approximately 16 months post implantation due to report of loosening.There are no supporting clinical/medical records or additional information provided regarding which component of the tka was loose, or whether any possible injury/trauma occurred.Several x-ray images have been provided and reviewed.Due to the low image quality it can¿t be confirmed but there appears to be a radiolucent line around the tibial post and possibly the anterior portion of the femoral component.The root cause of the reported loosening is not able to be determined, as the explanted devices were not returned for analysis.The patient impact beyond the revision surgery cannot be concluded as there is no report of the patient¿s current condition or how the procedure was tolerated.No further clinical assessment is warranted.A review of manufacturing records did not reveal any deviations that could have contributed to this issue.A review of manufacturing records revealed that we have not had any previous complaints for the listed lots.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.If additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: LEGION CR OXIN FEM SZ3 RT
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6880355
• Report Number: 1020279-2017-00768
• Device Sequence Number: 13631435
• Product Code: JWH
• UDI-Device Identifier: 00885556029718
• UDI-Public: 00885556029718
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2018

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: 09/27/2025
• Device Catalogue Number: 71421223
• Device Lot Number: 15JM21104
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2017
• Supplement Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 09/20/2017
• Supplement Report FDA Received Date: 05/28/2018
• 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: INSERT: PN#71453101 LOT#14AM08916; TIBIA: PN#71420180 LOT#14CT40570
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR