MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION POROUS HA TIBIAL BASE SZ 4 LT; PROST, KNEE, PATE/FEMOR, SEMI-CONS, UNCE, PORO, COAT, POLY/METAL/POLY

Model Number	71934056
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/21/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented aseptic loosening on the tibial baseplate of the left knee.This was noticed when the radiographic images showed radiolucencies on that component.It is unknown how the complication was treated.
Additional Manufacturer Narrative
The device, intended for use in treatment, was not returned for evaluation and the reported event could not be confirmed.The device was manufactured in 2014.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.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 the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of the risk management file and instructions for use document for this failure mode was conducted and concluded this failure mode has been identified.Our clinical/medical team noted: no clinical information has been provided for inclusion in this medical investigation.Therefore, a thorough medical investigation cannot be rendered.Should any additional medical information be provided this complaint will be re-assessed.At this time a definite root cause could not be determined.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: LEGION POROUS HA TIBIAL BASE SZ 4 LT
• Common Device Name: PROST, KNEE, PATE/FEMOR, SEMI-CONS, UNCE, PORO, COAT, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9814225
• Report Number: 1020279-2020-00826
• Device Sequence Number: 643658
• Product Code: MBH
• UDI-Device Identifier: 00885556143452
• UDI-Public: 00885556143452
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K100897
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2020

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: No Information
• Device Expiration Date: 06/23/2024
• Device Model Number: 71934056
• Device Catalogue Number: 71934056
• Device Lot Number: 14BM07212A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 11/12/2020
• 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