MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CONQUEST FN 7.5MMX90MM P-L SCR 20MM THD; DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT

Model Number	75807090
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/03/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision was performed due to conquest-fracture collapsed (so it was converted to total hip).The patient did not fall but was complaining of pain.They found in x-rays broken screws.
Additional Manufacturer Narrative
Results of investigation: the devices, used in treatment, was returned for evaluation.The devices were manufactured in 2015 and 2016.A review of the device history records for the listed batches did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.A review of the risk management file and instructions for use document for this failure mode was conducted and concluded this failure mode has been identified.The quality lab concluded that the plate experienced a high-energy ductile fracture.This fracture may have been caused by scratching the plate during implanting the device.The screws fractured by the initiation and subsequent propagation of fatigue cracking.The fatigue cracking eventually propagated to an extent that the remaining crosssectional area of the screws could not bear the imposed patient loading, which lead to an overload fracture.If one of the screws fractured, the remaining screws would have been subjected to higher stresses causing them to suffer fatigue fractures as well.The fracture origin could not be located using sem.Fatigue cracking is caused by the screws bearing cyclic stresses in excess of the material endurance limit for an extended period of time.These 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, and/or poor bone quality.Our clinical/medical team noted: the photo provided shows the plate that was cut shorter prior to implantation and the broken screws.Four unlabeled, undated x-ray confirms the broken screws but does not indicate a definite reason for break.The contours of the original femoral neck fracture cannot be appreciated so non-union cannot be ruled out but revision documentation was not provided to confirm.It cannot be ruled out that the shortening of the plate and the resulting change in load on the plate contributed the broken screws.Based on the product evaluation, the conquest fn screws fractured by the initiation and subsequent propagation of fatigue cracking also the plate experienced a high-energy ductile fracture was from trimming prior to the implant as demonstrated in the x-ray.Without the revision report or medical history, the root cause of the origin of the implant fracture and pain cannot be concluded.We cannot rule out excessive patient activity prior to full bone union, change in the plate size and load handling capabilities, applications of loads in excess of the material¿s strength, and/or poor bone quality as contributing factors.Since this issue was resolved by conversion to a total hip, the impact to the patient was the revision and expected pain in the post ¿operative period.Should any relevant clinical information be provided, this complaint would be re-evaluated.No further clinical/medical assessment is warranted at this time.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: CONQUEST FN 7.5MMX90MM P-L SCR 20MM THD
• Common Device Name: DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9727369
• Report Number: 1020279-2020-00631
• Device Sequence Number: 16679151
• Product Code: JDO
• UDI-Device Identifier: 00885556530245
• UDI-Public: 00885556530245
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K152686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/20/2026
• Device Model Number: 75807090
• Device Catalogue Number: 75807090
• Device Lot Number: 16EPU0005A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 46 YR