MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN HK LINK ASSY SZ 2-5 FEM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71421631
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/22/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
A revision surgery was performed due to a legion hk femoral component broken.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical analysis indicated that this case reports that a revision surgery was performed due to a broken legion hk femoral component.The date of implantation is unknown.One undated x-ray taken before the revision was provided which shows a femoral component of a legion hinge system anteriorly dislocated due to the broken link assembly.Details to indicate a reason for the broken piece are not apparent.Details regarding the patient¿s implant history, medical history, bone quality, fall/trauma history, and other additional clinical relevant information have not been provided.Based on the limited information provided and without the return of the device for evaluation the root cause for the reported broken component cannot be determined.Should additional information become available this issue can be re-elevated.No further clinical assessment is warranted at this time.The batch info was not provided and is not visible on the device in the photos.Without the actual product involved our investigation cannot proceed.Provided photos of the devices indicated that the link, hyperextension stop (with plugs), axel, bolt, and insert were damaged, with some portions broken.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.If the devices are received in the future, this complaint can be re-opened.
Additional Manufacturer Narrative
Additional information: concomitant medical products.

• Brand Name: LGN HK LINK ASSY SZ 2-5 FEM
• 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: 8334147
• Report Number: 1020279-2019-00552
• Device Sequence Number: 1578102
• Product Code: KRO
• UDI-Device Identifier: 00885556414873
• UDI-Public: 00885556414873
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K081111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2019

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 Catalogue Number: 71421631
• Device Lot Number: 13CBP0037
• Initial Date Received by Manufacturer: 01/22/2019
• Supplement Date Received by Manufacturer: 01/22/2019; 01/22/2019
• Initial Report FDA Received Date: 02/12/2019
• Supplement Report FDA Received Date: 09/02/2019; 09/30/2019
• 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: 71421687 / 12KTM0006; LEGION HK ISRT; LGN HK AXLE FEMUR; LGN HK HYPEREXT STOP W/AX PLUG; LGN OFFSET COUPLER
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention