MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HK TIBIAL BASE SZ 5 LT; PRSTHSIS,KNEE,FMORTIBL,CNSTRIN,CMNTDMTALPOLYMR

Model Number	71421305
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to implant loosening.Hinge stress caused the fixation implants to be loose.Primary surgery performed on (b)(6) 2015.
Additional Manufacturer Narrative
Results of investigation: the devices, used in treatment, were not returned for evaluation, and the reported event could not be confirmed.A clinical analysis indicated that without product return for evaluation and/or clinically relevant supporting documentation, a thorough medical investigation could not be performed.Reportedly a revision surgery was performed due to implant loosening secondary to hinge stress.The patient impact beyond the reported loosening and revision could not be determined.Should clinical documentation become available in the future, the clinical/medical task may be re-evaluated.No further medical assessment is warranted at this time.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 fit/sizing, traumatic injury, abnormal motion over time, design of device, bone degeneration, and lifetime of device.Without the return of the actual product involved and no patient medical records, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.No further investigation warranted for this complaint; however we 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: LEGION HK TIBIAL BASE SZ 5 LT
• Common Device Name: PRSTHSIS,KNEE,FMORTIBL,CNSTRIN,CMNTDMTALPOLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9770106
• Report Number: 1020279-2020-00723
• Device Sequence Number: 11415955
• Product Code: KRO
• UDI-Device Identifier: 00885556109137
• UDI-Public: 00885556109137
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2020

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: Health Professional
• Device Model Number: 71421305
• Device Catalogue Number: 71421305
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 11/17/2020
• 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