MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 3.5/4.5 PP DIS FEM PL R 20H 405MM; PLATE, FIXATION, BONE

Catalog Number	72585220
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Failure of Implant (1924); Deformity/ Disfigurement (2360); No Clinical Signs, Symptoms or Conditions (4582); Loss of fracture reduction (4901)
Date of Event	05/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate to known inherent device and/or 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 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, after an internal fixation surgery had been performed on an unknown date, the plate and screws of one (1) evos 3.5/4.5 pp dis fem pl r 20h 405mm pulled out of the patient's bone.This adverse event was solved by a revision surgery on (b)(6) 2025, in which the hardware was removed.The current health status of the patient is unknown.
Additional Manufacturer Narrative
H11: internal complaint reference (b)(4).H2: corrected data: h6: health effect - clinical code.H3, h6: the associated device was returned and evaluated.The visual inspection revealed the threaded slots and tabs deformed in several areas.The inferior surface is scratched and scuffed.The clinical/medical investigation concluded that, the x-rays confirm the report that the plate and screws had pulled out of the bone as well as bowing of the femoral shaft.Based on the limited information provided, the definitive clinical root cause of the reported adverse event could not be determined.Although we could not rule out a compromised bone quality due to the patient¿s age, trauma, mechanical overload, premature weight bearing, nutritional status, micromotion at the implant site, or delayed fracture healing as likely contributing factors.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 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 instructions for use documents for evos¿ plating system revealed in warnings section that it is extremely important to select the appropriate size and type components.Failure to use the largest possible components or improper positioning may result in loosening, bending, cracking, or fracture of the device or bone or both.Besides, the precautions section stablishes that postoperative instructions to patients and appropriate nursing care are critical.Early load bearing substantially increases implant loading and increases the risk of loosening, bending or breaking the device.Early load bearing should only be considered where there are stable fractures with good bone-to-bone contact.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.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
Internal reference number: (b)(4).
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.The visual inspection revealed the threaded slots and tabs deformed in several areas.The inferior surface is scratched and scuffed.The clinical/medical investigation concluded that, the x-rays confirm the report that the plate and screws had pulled out of the bone as well as bowing of the femoral shaft.Based on the limited information provided, the definitive clinical root cause of the reported adverse event could not be determined.Although we could not rule out a compromised bone quality due to the patient¿s age, trauma, mechanical overload, premature weight bearing, nutritional status, micromotion at the implant site, or delayed fracture healing as likely contributing factors.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 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 instructions for use documents for evos¿ plating system revealed in warnings section that it is extremely important to select the appropriate size and type components.Failure to use the largest possible components or improper positioning may result in loosening, bending, cracking, or fracture of the device or bone or both.Besides, the precautions section stablishes that postoperative instructions to patients and appropriate nursing care are critical.Early load bearing substantially increases implant loading and increases the risk of loosening, bending or breaking the device.Early load bearing should only be considered where there are stable fractures with good bone-to-bone contact.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.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: EVOS 3.5/4.5 PP DIS FEM PL R 20H 405MM
• Common Device Name: PLATE, FIXATION, BONE
• 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: 22288681
• Report Number: 1020279-2025-01090
• Device Sequence Number: 8467855
• Product Code: HRS
• UDI-Device Identifier: 00885556771136
• UDI-Public: 885556771136
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K213126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup,Followup
• Report Date (Section B): 10/30/2025

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 Catalogue Number: 72585220
• Device Lot Number: 22BM02881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 09/22/2025; 10/16/2025; 10/22/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 10/10/2025; 10/17/2025; 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2021
• 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: Other; Required Intervention
• Patient Sex: Unknown