MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN XLPE DISHED ISRT SZ 3-4 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71453281
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Laceration(s) (1946); Joint Dislocation (2374); Unspecified Tissue Injury (4559)
Date of Event	05/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a patient complication reported that includes reference to the use of a smith+nephew product without evidence about 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 submitting this report in accordance with applicable regulations.If additional investigative findings or 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 following a tka performed on (b)(6) 2025, the patient experienced a tibial dislocation while attempting to move herself down the bed.Dr.(b)(6) noted that the posterior capsule appeared to remain intact and attributed the dislocation to a levering action during simultaneous knee flexion and internal rotation.The adverse event was addressed with a revision surgery on (b)(6) 2025.During this procedure, one (1) legion¿ cr oxin fem sz3 lt and one (1) lgn xlpe dished insert sz 3-4 15mm were removed.It was determined that a posterior-stabilised knee implant would be more appropriate to prevent recurrence.While removing the well-cemented femoral component, a significant amount of bone remained attached to the implant.As a result, a revision femoral prosthesis with a stem and augments was used to compensate for the bone loss.The post on the posterior-stabilised polyethylene insert successfully prevented further dislocation, allowing the tibial component to be left in situ.Patient is recovering well.
Additional Manufacturer Narrative
Additional information: h6 (health effect - clinical code, health effect - impact code [f1907 removed] and type of investigation), h8 and h11.H11: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, based on the surgeon¿s statement, ¿the posterior capsule appeared to be intact, and the dislocation was attributed to a levering action during simultaneous knee flexion and internal rotation.¿ although a procedural variance could not be ruled out as a contributing factor¿especially considering the reported soft tissue complications during the primary surgery¿other elements may have also played a role.These include the use of a thicker-than-usual 15mm polyethylene insert for stability despite ¿normal cuts,¿ excessive cement application, and the removal of a well-cemented femoral component, which resulted in significant bone loss.According to the report, the patient is currently recovering well.A review of the production order for both the insert and the femoral component 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 batches number 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 legion¿ total knee system revealed that dislocation has been identified in adverse events as result from trauma, improper implant selection, improper implant positioning, improper fixation, and/or migration of the components.Muscle and fibrous tissue laxity can also contribute to these conditions.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 this products and event.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 injury, patient condition, postoperative care, size selected or abnormal loading of limb.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.Internal complaint reference: (b)(4).

• Brand Name: LGN XLPE DISHED ISRT SZ 3-4 15MM
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 22184554
• Report Number: 1020279-2025-01045
• Device Sequence Number: 8690997
• Product Code: JWH
• UDI-Device Identifier: 00885556255674
• UDI-Public: 885556255674
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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
• Report Date (Section B): 07/15/2025

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: 71453281
• Device Lot Number: 24DM16893
• 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: 05/21/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2024
• 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: PN: 71421233 / LOT: 24CM10697
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown