MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FEMORAL IMPLANT IMPACTOR; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number	71440005
Medical Device Problem Codes	Degraded (1153); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a tkr surgery, the black plastic bumper of one (1) femoral implant impactor was fractured and fatigue.The piece was completed and nothing was left in the patient.The procedure was resumed, without any delay, using the same device.

• Brand Name: FEMORAL IMPLANT IMPACTOR
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, 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: 25203531
• Report Number: 1020279-2026-00654
• Device Sequence Number: 10010098
• Product Code: JDG
• UDI-Device Identifier: 00885556034156
• UDI-Public: 885556034156
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K123598
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2026

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: 71440005
• Device Lot Number: 15GM10832
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2026
• Supplement Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 05/18/2026
• Supplement Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown