MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HK 15MM BOLT - SLEEVE; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71421387
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	01/30/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision of insert and legion hinge mechanism due to instability of de knee.Patient was walking and suddenly the knee felt unstable and she wasn¿t able to walk further.She didn¿t fall or injured herself in any way.We opened the knee and found some metalized tissue.Removing the bolt was very easy.We weren¿t able to remove the sleeve without first detaching the hinge mechanism.So we removed the mechanism according the surgical technique.Because the sleeve was still in the lgn hk link assy sz 2-5 fem, we weren¿t able to remove the lgn hk link assy sz 2-5 fem.Finally we turned the lgn hk link assy sz 2-5 fem 180 degrees and unscrewed the insert.With some force we managed to get the lgn hk link assy sz 2-5 fem and sleeve out of the tibia.We saw some black residue on the tibia base at the position of the insert screw.It looked like metalized residue as well.
Additional Manufacturer Narrative
Results of investigation: the associated complaint devices were returned and evaluated.A visual examination indicated that there were signs of scratching on several of the as-received components that may have been due to the reported instability.The remaining hinge components were not received; therefore further analysis could not be conducted.The immediate cause of the instability could not be determined.No material or manufacturing deviations were observed in this investigation.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A clinical analysis indicated based on the information available, the root cause of the ¿instability¿ and reported scratches cannot be concluded.No report as to the patient¿s current status has been submitted.Based on this investigation, the need for corrective action is not indicated.No further investigation is 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 15MM BOLT - SLEEVE
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7279462
• Report Number: 1020279-2018-00196
• Device Sequence Number: 10982176
• Product Code: KRO
• UDI-Device Identifier: 00885556030004
• UDI-Public: 00885556030004
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K081111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2018

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: Lay User/Patient
• Device Catalogue Number: 71421387
• Device Lot Number: 13TJM0022E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 01/30/2018; 01/30/2018
• Initial Report FDA Received Date: 02/17/2018
• Supplement Report FDA Received Date: 02/19/2018; 06/30/2018
• 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: 94