MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ECH PRI FEM COMP SO SZ 11; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71341011
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/21/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka surgery had been performed, the echelon femoral component broke in the femoral canal as shown by x-ray images.A revision surgery was performed to remove and replace the broken prosthesis.The patient outcome is unknown.
Additional Manufacturer Narrative
The device, used in treatment was not returned for evaluation.Without the actual product, product evaluation could not be performed and complaint could not be confirmed.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.According to clinical/medical investigation , per complaint details, within 2 years of implantation ¿x-rays showed the stem had broken in the femoral canal¿ for which the patient underwent a subsequent revision.It is possible that inadequate proximal femoral support, micro-motion, and body habitus could have been contributing factors to the reported event, although the root cause could not be definitively concluded based solely on the single x-ray image provided.The patient impact beyond the reported stem fracture, subsequent revision and an expected transient rehabilitative period could not be determined based on the limited information provided.No further medical assessment can be rendered at this time.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Possible causes could include but not limited to traumatic injury, surgical technique or size of device.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further actions are being taken at this time.We consider this investigation closed.Credit will not be issued for the device.

• Brand Name: ECH PRI FEM COMP SO SZ 11
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10065516
• Report Number: 1020279-2020-01770
• Device Sequence Number: 10906124
• Product Code: JDI
• UDI-Device Identifier: 03596010438751
• UDI-Public: 3596010438751
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K983834
• 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): 01/29/2021

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: 71341011
• Device Lot Number: 17EM18306
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/21/2020
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 05/18/2020
• Supplement Report FDA Received Date: 01/30/2021
• 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