MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 7-8 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71453231
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Subluxation (4525)
Date of Event	12/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after tka surgery was performed on (b)(6) 2016, the patient presented to surgeon with subluxation in knee.It was determined by the surgeon that the post of the lgn ps high flex xlpe sz 7-8 9mm that was originally implanted had broken.A knee revision was performed on (b)(6) 2023 to replace the poly to a constrained version.Patient's current health status is unknown.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.The visual inspection revealed the post fractured off the device.The post was returned.The visual also reveals discoloration, scratches and deep gouges in the device.The knee insert post deformation and/or fracture may have been due to repeated posterior contact of the femoral cam on the post combined with excessive posterior to anterior shear force during activity.However, this could not be isolated as the root cause for this particular failure mode.Some additional factors that could have contributed to the reported event include patient anatomy, abnormal loading of limb and/or traumatic injury.The clinical/medical investigation concluded that, per complaint details, an insert revision (exchange for a constrained version) was performed 7 years post-total knee arthroplasty due to subluxation in the knee and it was determined by the surgeon that the insert-post had broken.It was communicated that the requested clinical documentation was not available.Based on the limited information provided, definitive contributing clinical factors cannot be concluded.The instructions for use in possible adverse events does address subluxation, unusual stress concentrations, etc.And does note that the implant can fracture/ may require future revision and contributing factors may include strenuous activity, duration of service, and muscle and fibrous tissue laxity among other possible factors.The current patient status is unknown.Patient impact beyond the reported revision secondary to subluxation and broken insert post cannot be determined.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.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 this product and event.According per material specification, the quality and manufacture of polyethylene bar shall be controlled.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should 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: LGN PS HIGH FLEX XLPE SZ 7-8 9MM
• 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: 18466050
• Report Number: 1020279-2024-00050
• Device Sequence Number: 15220377
• Product Code: JWH
• UDI-Device Identifier: 00885556034620
• UDI-Public: 00885556034620
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 02/09/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/30/2025
• Device Catalogue Number: 71453231
• Device Lot Number: 15GT57354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2015
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown