MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM L-D FEM LK PL13H R 286MM; PLATE, FIXATION, BONE

Model Number	71800113
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Hip Fracture (2349); Swelling/ Edema (4577)
Date of Event	01/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, 5 months after right femur internal fixation performed on an unknown date, the patient experienced a fall.They were able to walk thereafter until they noticed swelling on the injured site.It was later discovered through x-rays that the 4.5mm lateral distal femur locking plate was broken.Fracture of the lateral plate along with re-fracture of the femur shaft was observed.This adverse event was treated with a revision on (b)(6) 2023, in which a competitor's plate (zimmer) was placed in exchange.The post-revision of the internal fixation alignment was determined to be satisfactory.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.The visual inspection revealed the plate fractured into two pieces.Several screws were returned with the plate as well.A laboratory analysis performed on the device revealed the peri-loc distal femur plate fractured by the initiation and subsequent propagation of fatigue cracking.The fatigue cracking eventually propagated to an extent that the remaining cross section could not bear the imposed patient loading, which led to a partial fracture.Fatigue cracking is caused by the plate bearing cyclic stresses in excess of the material endurance limit for an extended period.These excessive cyclic stresses may be caused by any number of conditions, including but not limited to excessive patient activity levels prior to full bone union applications of loads in excess of the material¿s strength, or poor bone quality.No material or manufacturing deviations were observed during this investigation.The clinical/medical investigation concluded that, the information for use makes a special note that the implant is an aid to healing and not a substitute for normal bone; therefore, the strength of implant is limited.The patient impact beyond the reported ¿minor fall¿, onset of swelling, periprosthetic fracture with plate breakage and subsequent revision could not be determined, although a transient post-operative rehabilitative phase would be anticipated.No further medical assessment can be rendered at this time.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 revealed similar events 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 fracture fixation devices revealed in adverse effects that dislocation may result from improper selection of the neck length and cup, stem positioning, muscle looseness and/or malpositioning of components.Also, according to warnings, the correct selection of device components is extremely important.The appropriate type and size should be selected for the patient.Failure to use the largest possible components or improper positioning may result in cracking, or fracture of the device or bone or both.Additionally, the precautions section reveals that postoperative instructions to patients and appropriate nursing care are critical.Early weight bearing substantially increases implant loading and increases the risk of loosening, bending or breaking the 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.According with inspection procedure, the final inspection includes the verification of part configuration per print.Also, material specification shall control the quality and manufacture of type 316l stainless steel for surgical implants.At this time, we have no reason to suspect 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 as the patient fall was most likely the contributing factor to the reported event.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: 4.5MM L-D FEM LK PL13H R 286MM
• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16297422
• Report Number: 1020279-2023-00243
• Device Sequence Number: 7455504
• Product Code: HRS
• UDI-Device Identifier: 03596010520098
• UDI-Public: 03596010520098
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K092015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2023

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 Model Number: 71800113
• Device Catalogue Number: 71800113
• Device Lot Number: 20GM04941
• 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: 01/09/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2020
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female