MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN FEM CONE IMPACTOR HEAD ID 20MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	71441977
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during tha surgery, one of the spring-loaded locking mechanism of one (1) lgn fem cone impactor head id 20mm broke while implanting.The screw fell out.It was recovered and disposed of properly at the facility.All pieces were accounted for after the case.The procedure was resumed, after a non-significant delay, using the same device.No further complications were reported.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.The visual inspection revealed that the device presents with wear from use, one of the press fit long nose spring plungers is fractured with the center not returned, the surfaces discolored, scratched and scuffed.The entire device is worn from use.The instrument has been in distribution for several years and may show wear from repeated use, cleaning, or possible misuse.Surgical instruments naturally experience wear over time and may eventually fail to perform as intended.Since there is no evidence of a manufacturing defect, reviewing device history records is not necessary, as manufacturing issues are unlikely to be a contributing factor in this case.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 listed device.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.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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 FEM CONE IMPACTOR HEAD ID 20MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• 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: 24044981
• Report Number: 1020279-2026-00048
• Device Sequence Number: 9260326
• Product Code: MBH
• UDI-Device Identifier: 00885556536964
• UDI-Public: 885556536964
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K162775
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71441977
• Device Lot Number: 17BGA0013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown