MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HK GD MOTION ISRT 13MM SZ 6-7 RT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71423366
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	09/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference number (b)(4).
Event or Problem Description
It was reported that, after a previous tka revision performed around 2020 with legion hk, the coupling broke.A revision surgery was performed on (b)(6) 2023 to replace the components.Patient has indicated that four (4) weeks after the operation the new coupling is weakening again.Patient walks shorter distances with crutches and longer distances with a wheelchair.Patient's next appointment is scheduled for (b)(6) 2023.
Event or Problem Description
It was reported that, after a previous revision surgery to exchange the femoral construct of a legion hk system, the coupling broke.A revision surgery was performed on (b)(6) 2023 to replace the components.
Additional Manufacturer Narrative
B5, d6 have been updated.
Additional Manufacturer Narrative
Additional information: b3 (date of event), d6b (date of explantation), d7a, h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, based on the information provided, the patient multimorbidity (¿instability in myasthenia gravis¿) contributed to the reported event.In addition, the sub-optimal imaging appears to show incomplete fracture consolidation (b)(6) 2023 with possible radiolucency under the baseplate however, this cannot be definitively concluded based on these images alone.The patient impact reportedly included the ¿coupling weakening¿ in the presence of myasthenia gravis instability with subsequent revision with no broken components noted.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For both devices, a review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to these products and event.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include joint laxity, traumatic injury or patient condition.Based on this investigation, the need for corrective action is not indicated.Should the devices or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Corrected data: b1 (type of event updated), b5 (narrative), d10 (concomitant product identifiers added), e1,e2,e3,g2 (patient-reporter info updated), h6 (health effect - clinical code, medical device problem code).
Event or Problem Description
It was reported that, after a previous revision surgery to exchange the femoral construct of a legion hk system, the patient experienced instability in myasthenia gravis and that the coupling weakened.The patient could not explain exactly what happened with the prosthesis.A revision surgery was performed on (b)(6) 2023 to replace the coupling components.

• Brand Name: LEGION HK GD MOTION ISRT 13MM SZ 6-7 RT
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18050063
• Report Number: 1020279-2023-02128
• Device Sequence Number: 15473051
• Product Code: KRO
• UDI-Device Identifier: 00885556108642
• UDI-Public: 00885556108642
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K081111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2024

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?: Yes
• Device Expiration Date: 08/15/2024
• Device Catalogue Number: 71423366
• Device Lot Number: 14GM07242B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2023
• Supplement Date Received by Manufacturer: 10/22/2023; 01/05/2024
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 11/10/2023; 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LEGION HK 13MM BOLT - SLEEVE; PN: 71421386 / LOT: 17CTM0057B
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male