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

Model Number 72585118

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, the patient underwent an internal fixation surgery in or about (b)(6) 2022, in which in the left leg an unspecified smith and nephew trauma ortho device was implanted.Within six months post operation, the patient experienced a breakage of the device.This complication was solved by conducting a revision surgery on an unknown date in which the broken device was removed.Current health status of the patient and additional information are unknown.

Event Description

It was reported that, the plaintiff underwent an internal fixation surgery in or about (b)(6) 2022, in which the evos 3.5/4.5 pp dis fem pl l 18h 369mm was implanted.Within six months post operation, the patient experienced a breakage of the device.This complication was solved by conducting a revision surgery on an unknown date in which the broken device was removed.Current health status of the patient and additional information are unknown.

Manufacturer Narrative

H2: additional information ¿b5¿.H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that the provided x-rays were reviewed and show a broken fixation plate at the site of a femoral fracture just proximal to the left total knee arthroplasty femoral component ((b)(6) 2022).It was reported the patient had a revision.There were multiple images provided that show a distal femoral shaft fracture peri-prosthetic to the total knee femoral component at unknown date.This was plated the length of the femur which later was fractured seen in the (b)(6) 2022 dated image.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.With the limited information provided a clinical root cause of the reported broken internal fixation cannot be confirmed.Nonunion of initial peri-prosthetic fracture or patient activity cannot be ruled out as a factor.The patient impact is the reported broken internal fixation device and revision of the plate as well as re-stabilize the fracture with what appears internal fixation.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for plating systems revealed in precautions that postoperative instructions to patients and appropriate nursing care are critical.Early load bearing substantially increases implant loading and increases the risk of 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.According with the material specification, the quality and manufacture of special quality stainless steel bar, strip, and coil stock 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.Factors that could contribute to the reported event include size selected, surgical technique, postoperative care, patient anatomy, abnormal loading of limb, excessive forces and/or traumatic injury.Based on this investigation, the need for corrective action is not indicated.Should the device or 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.

Manufacturer Narrative

The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that the provided x-rays were reviewed and show a broken fixation plate at the site of a femoral fracture just proximal to the left total knee arthroplasty femoral component (b)(6) 2022.There were multiple images provided that show a distal femoral shaft fracture peri-prosthetic to the total knee femoral component at unknown date.This was plated the length of the femur which later was fractured seen in the (b)(6) 2022 dated image.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.With the limited information provided a clinical root cause of the reported broken internal fixation cannot be confirmed.Nonunion of initial peri-prosthetic fracture or patient activity cannot be ruled out as a factor.The patient impact is the reported broken internal fixation device and revision of the plate as well as re-stabilize the fracture with what appears internal fixation.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 plating systems revealed in precautions that postoperative instructions to patients and appropriate nursing care are critical.Early load bearing substantially increases implant loading and increases the risk of 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.According with the material specification, the quality and manufacture of special quality stainless steel bar, strip, and coil stock 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.Factors that could contribute to the reported event include size selected, surgical technique, postoperative care, patient anatomy, abnormal loading of limb, excessive forces and/or traumatic injury.Based on this investigation, the need for corrective action is not indicated.Should the device or 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.

Manufacturer Narrative

D1, d2a, d2b, d4, h4 (device information).

• Brand Name: EVOS 3.5/4.5 PP DIS FEM PL L 20H 405MM
• Type of Device: 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18544212
• MDR Text Key: 333259023
• Report Number: 1020279-2024-00185
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00885556771082
• UDI-Public: 885556771082
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203405
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72585118
• Device Catalogue Number: 72585120
• Device Lot Number: 21GM07088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Female