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

Model Number	71423356
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka surgery performed on (b)(6) 2021, the patient sustained an unspecified infection.A revision surgery was performed on (b)(6) 2023 to exchange the legion hk gd motion isrt 15mm sz 4-5 lt and legion hk 15mm bolt - sleeve to address this complication.The i & d was done to fight off infection.The current health status of the patient is unknown.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, per case details, approximately eighteen (18) months after a total knee arthroplasty surgery with legion hk gd motion isrt 15mm sz 4-5 lt and legion hk 15mm bolt - sleeve components, the patient reportedly ¿sustained an unspecified infection.¿ a subsequent revision (with exchange of the components) was performed, and an incision and drainage was reportedly performed to treat the unspecified infection.However, it was reported per a case communication, ¿the cause of the infection and insert exchange was not fault of the smith-nephew products initially implanted per the surgeon.¿ the patient impact beyond the reported cannot be determined.However, ¿the patient left surgery in good health.¿ therefore, no further clinical/medical assessment can be rendered.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the device did not reveal similar events for the listed devices.A review of the instructions for use documents for knee systems revealed that late deep wound sepsis and/or low-grade synovitis has been identified in the possible adverse effects section.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.A review of the sterilization records revealed the batches were sterilized within normal parameters.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 injury, patient condition and/or medical history.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.

• 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 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: 17162139
• Report Number: 1020279-2023-01336
• Device Sequence Number: 5589977
• Product Code: KRO
• UDI-Device Identifier: 00885556030271
• UDI-Public: 00885556030271
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K081111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2023

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: 12/15/2025
• Device Model Number: 71423356
• Device Catalogue Number: 71423356
• Device Lot Number: 15MM13404
• 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: 06/01/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2015
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71421387 / LOT# 19DTM0021H.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown