MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION PS OXIN FEM SZ5 RT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71421205
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Sepsis (2067)
Date of Event	07/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a tka surgery was performed on (b)(6) 2023, the patient experienced sepsis.This adverse event was treated by a revision surgery on (b)(6) 2023, in which a legion ps oxin fem sz5 rt, lgn ps high flex xlpe sz 3-4 11mm, gns ii cmt tib size 4 {} right and a gns ii resurf pat 29mm were exchanged.Patient's current health status is unknown.
Additional Manufacturer Narrative
The devices were not returned for evaluation; therefore, devices analysis could not be performed.The clinical/medical investigation concluded that, approximately four months post total knee arthroplasty, the patient had a first stage revision surgery in which the implants were removed and an antibiotic cement spacer was implanted due to sepsis.As of the date of this medical investigation, the requested clinical documentation has not been provided for evaluation.Therefore, there were no clinical factors found which would have contributed to the reported sepsis.The patient impact beyond the that which has already been reported cannot be determined with the limited information.However, it was reported the patient¿s current health status is healthy and the second stage revision is scheduled for september 5, 2023.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 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 femoral component.A review of complaint history revealed a similar event for the insert and the tibial baseplate over the previous 12 months, but no similar events for the batch based on the historical data.A review of complaint history revealed similar events for the patella over the previous 12 months, but no similar events for the batch based on the historical data.A review of the instructions for use documents for knee systems revealed acute post-surgical wound infection and local infection or previous intra-articular infections, this has been identified as possible adverse effects and contraindications for total knee replacement.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 loss of sterility during procedure, post-operative healing issue, 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.
Additional Manufacturer Narrative
B5: describe event or problem and b7: other relevant history, including preexisting medical conditions.
Event or Problem Description
It was reported that, after a tka surgery was performed on (b)(6) 2023, the patient experienced sepsis.This adverse event was treated by a revision surgery on (b)(6) 2023, in which a legion ps oxin fem sz5 rt, lgn ps high flex xlpe sz 3-4 11mm, gns ii cmt tib size 4 {} right and a gns ii resurf pat 29mm were exchanged.Currently, the patient is healthy and has been scheduled for a legion revision hinge surgery on (b)(6).

• Brand Name: LEGION PS OXIN FEM SZ5 RT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: 17368077
• Report Number: 1020279-2023-01485
• Device Sequence Number: 7061886
• Product Code: JWH
• UDI-Device Identifier: 00885556030622
• UDI-Public: 00885556030622
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/22/2023

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 Model Number: 71421205
• Device Catalogue Number: 71421205
• Device Lot Number: 21EM01841
• 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: 07/02/2023
• Supplement Date Received by Manufacturer: 08/02/2023; 08/17/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 08/07/2023; 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2021
• 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: GNS II CMT TIB SIZE 4 {} RIGHT, LOT: G2214203; GNS II RESURF PAT 29MM, LOT: 17BM09286; LGN PS HIGH FLEX XLPE SZ 3-4 11MM LOT: 22LM11067
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female