MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION PS OXIN FEM SZ7 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71421217
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	02/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a reported patient complication that includes reference to the use of a smith+nephew product without evidence of a specific product problem.The reported complication relates to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, after tka surgery had been performed on (b)(6) 2021, the patient experienced infection.This adverse event was solved by a revision surgery on (b)(6) 2025, in which one (1) gns ii con ins sz5-6 11mm was explanted.Patient's current health status is unknown.No further complications were reported.
Event or Problem Description
It was reported that, after tka surgery had been performed on (b)(6) 2021 and a first revision surgery on (b)(6) 2024 ((b)(4)), the patient experienced infection.This adverse event was solved by a revision surgery on (b)(6) 2025, in which the legion ps oxin fem sz7 lt and the gns ii con ins sz5-6 11mm were explanted.Patient's current health status is unknown.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.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 that acute post-surgical wound infection has been identified as a possible adverse effect.Active, local infection or previous intra-articular infections are identified in contraindications for total knee replacement.A review of the risk management file 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 evidence to conclude 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.
Event or Problem Description
It was reported that, after tka surgery had been performed on (b)(6) 2021, and a subsequent first revision surgery conducted on (b)(6) 2024 (b)(4)) due to joint instability, the patient developed an infection.This adverse event was addressed through a second revision surgery on (b)(6) 2025, which was carried out in two distinct stages.During the initial stage, the legion ps oxin fem sz7 lt and the gns ii con ins sz5-6 11mm prosthetic components were explanted.In their place, a gii p/s all poly tb sz5 15mm lt and a legion ps np fem sz7 lt were implanted as temporary devices.Upon resolution of the infection, the second stage of the revision surgery was performed on (b)(6) 2025 (initially reported under case- (b)(4)).At this time, the all-poly tibial component and a ps cocr femoral component were removed, and definitive legion revision components were implanted.The patient left surgery in good health.
Additional Manufacturer Narrative
Additional information: b5, d10, h6 (health effect - impact code), h10 (additional information initially reported under mdr no.1020279-2025-01103 now is cover under this report).Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
The devices were not returned for evaluation; therefore, a device analysis could not be performed.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 acute post-surgical wound infection has been identified as a possible adverse effect.Active, local infection or previous intra-articular infections are identified in contraindications for total knee replacement.A review of the risk management file 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 evidence to conclude 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.

• Brand Name: LEGION PS OXIN FEM SZ7 LT
• 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: 21586731
• Report Number: 1020279-2025-00465
• Device Sequence Number: 8757809
• Product Code: JWH
• UDI-Device Identifier: 00885556030882
• UDI-Public: 885556030882
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• 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,Followup,Followup
• Report Date (Section B): 08/22/2025

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: 71421217
• Device Lot Number: 21BM09620
• 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: 02/19/2025
• Supplement Date Received by Manufacturer: 03/27/2025; Not provided; 08/19/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 04/21/2025; 07/28/2025; 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2021
• 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: GII P/S ALL POLY TB SZ5 15MM L: 71420390,18KM25138; GNS II CON INS SZ5-6 11MM: 71420538, P2408634; GNS II CON INS SZ5-6 11MM: 71420538, P2408634; LEGION PS NP FEM SZ 7 LT: 71423227, 24GL00854
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown