MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 7-8 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71453233
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	04/15/2025
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 had been performed on (b)(6) 2016, the patient experienced a breakage of one (1) lgn ps high flex xlpe sz 7-8 13mm.This adverse event was solved by a revision surgery on (b)(6) 2025, in which implant and broken piece were retrieved.Current health status of the patient is unknown.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device finds the legion high flex insert significantly worn and discolored.One area of the posterior edge of the superior surface is deformed with significant material loss and the post is severely degraded.The insertion/extraction slot on the inferior surface is fractured and the lock detail is slightly deformed in several areas.The clinical/medical investigation concluded that based on the appearance of the explanted insert, wear over the approximate 9 years in-vivo likely contributed to the reported breakage.It is unknown to what extent the wear may have contributed to the reported adverse event.Therefore, a definitive clinical root cause of the reported breakage could not be determined.The patient impact beyond the reported the subsequent revision and a transient post-operative period cannot be determined since the patient¿s outcome is unknown.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A laboratory analysis performed on the device revealed that the retrieved lgn ps hf xlpe sz 7-8 13mm was examined using visual and macroscopic/microscopic methods.Visual examination showed fracture of the post, yellowish discoloration of the polyethylene material, scratches on the locking foot and on the curved anterior face, and deformation damage in the extraction slot.The post was fractured approximately midway up the post of the insert with damage on the posterior side closer to the base.Yellowish discoloration of the polyethylene materials of implants can occur when exposed to fluids in or around a joint.Extraction damage can be created by the removal instrumentation used during the extraction of the implants.Macroscopic/microscopic examination showed wear, burnishing, and pitting on the articular surface; delamination near the posterior edges of the condyle articular surfaces; damage to the post region surfaces; and deformation of the leading edges of the anterior lock detail.A review of complaint history revealed a similar event 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 instructions for use documents for knee systems revealed in warnings and precautions that the implant can break or become damaged as a result of strenuous activity or trauma.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 with inspection drawing, the final inspection includes the verification of part configuration per print.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event patient anatomy, abnormal loading of limb, excessive forces and/or injury.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.
Additional Manufacturer Narrative
Corrected data: h6.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 7-8 13MM
• 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: 21976750
• Report Number: 1020279-2025-00787
• Device Sequence Number: 9188251
• Product Code: JWH
• UDI-Device Identifier: 00885556033524
• UDI-Public: 885556033524
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: 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
• Report Date (Section B): 10/20/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/29/2024
• Device Catalogue Number: 71453233
• Device Lot Number: 14HT45617
• 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: 04/15/2025
• Supplement Date Received by Manufacturer: 06/10/2025; 10/20/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 06/13/2025; 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2014
• 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: Required Intervention
• Patient Sex: Unknown