MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM PROX FEMUR LCK PLATE 12H R 288MM; PLATE, FIXATION, BONE

Catalog Number	74800512
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient fell down approx 6 weeks ago.Due to ongoing pain, an x-ray of her right hip was taken on (b)(6) 2019.This showed a break in her femur and femoral plate that was fixed on (b)(6) 2017.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.The lab analysis concluded, during this investigation, it was concluded that the proximal femur plate fractured by the initiation and subsequent propagation of fatigue cracking.The fatigue cracking eventually propagated to an extent that the remaining cross-sectional area of the locking plate could not bear the imposed patient loading, which lead to an overload fracture.Fatigue cracking is caused by the plate bearing cyclic (repeated) stresses in excess of the material endurance limit for an extended period of time.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, and/or poor bone quality.No material deviations in the locking plate were found during this investigation.The clinical/medical team concluded, neither the request clinical information nor the primary/revision operative reports were provided.However, the two x-rays provided confirms the reported fracture but it cannot be concluded if the femoral fracture and result of the fall or is a non-union.Based on the product evaluation the proximal femur plate fractured by the initiation and subsequent propagation of fatigue cracking which was likely as caused by the report fall.However, we cannot rule out the patient¿s age, cognitive status, bone quality, and excessive patient activity levels prior to full bone union as contributing factors to the reported issue.The impact to the patient beyond the revision, rehab and post-operative pain cannot be concluded.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.

• Brand Name: 4.5MM PROX FEMUR LCK PLATE 12H R 288MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8292167
• Report Number: 1020279-2019-00345
• Device Sequence Number: 1691237
• Product Code: HRS
• UDI-Device Identifier: 03596010611321
• UDI-Public: 03596010611321
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K072818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2019

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 Catalogue Number: 74800512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 07/02/2019
• 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: Other; Required Intervention