MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HK GD MOTION ISRT 15MM SZ 4-5 LT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71423356
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/21/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to joint instability.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, several attempts have been made to obtain clinical/medical documents to no avail.Without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available, this complaint can be re-assessed.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.A lab analysis indicated that the plastic insert had minimal wear, and the metal components are lightly burnished.The hinge link assembly has a fractured post bushing that is inside of the link.The axle plugs are fractured and deformed.There were no observations of material or manufacturing deviations in the course of 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 review of complaint history for the listed part did not reveal additional complaints for the listed batches.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 GD MOTION ISRT 15MM SZ 4-5 LT
• 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: 7590256
• Report Number: 1020279-2018-01106
• Device Sequence Number: 19286122
• Product Code: KRO
• UDI-Device Identifier: 00885556030271
• UDI-Public: 00885556030271
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K081111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/29/2018

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: 08/26/2023
• Device Catalogue Number: 71423356
• Device Lot Number: 13HM20430
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 05/21/2018; 05/21/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 08/07/2018; 11/29/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71421683/12JTM0014; 71421688/12LTM0008; 71421938/14KTM0011; UNKNOWNUNKNOWN
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention