MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ECHELON HA STD 260 BOW S 15 L; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALIC

Model Number 71344415

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 08/23/2020

Event Type  Injury  

Event Description

It was reported that a left total hip revision surgery was performed due to periprosthetic fracture.Previous to this revision another revision surgery was performed on (b)(6) 2020 which was also performed for periprosthetic fracture (distal to femoral prosthesis (not a smith and nephew product)) for this surgery an echelon stem was implanted with oxinium head but patient refractured proximal femur.Revision surgery was performed, removing stem and femoral head.A new larger femoral stem implanted, and femur cabled with strut bone graft for additional support.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

It was reported that a patient undergoing rehab post-tha revision required a second revision due to a refractured proximal femur approximately 3 weeks post-first revision.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.A clinical analysis noted that the provided undated/unidentified x-ray appears to show a free-floating lesser trochanter and severely comminuted proximal femoral fracture which extends distally into the proximal 1/3 of the femur.The post-op image also shows additional hardware used for additional support of the severely comminuted proximal femoral fractures.The provided photo of explanted components appears to show intact components without bone-ingrowth on the stem or any visible component fracture.Based on the documentation provided, the root cause of the reported event was most likely the non-union of the previous periprosthetic fracture/re-fracture with possible inadequate anatomical reduction/femoral support and possible excessive early post-op weight-bearing, although significant bony union would not have been anticipated at 3 weeks post-implantation it was likely a result of the stability of the remaining bone that was available after the first revision and not a failure of the sn stem and ball head.Reportedly, the first revision was performed for a periprosthetic fracture distal to a non-sn femoral prosthesis.It remains unknown if the primary and/or first revision tha were a mixed manufacturer construct, as the shell and liner were not identified.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, this complaint will be reopened and reevaluated.We consider this investigation closed.

• Brand Name: ECHELON HA STD 260 BOW S 15 L
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10543558
• MDR Text Key: 207231078
• Report Number: 1020279-2020-04628
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 00885556023525
• UDI-Public: 00885556023525
• Combination Product (y/n): N
• PMA/PMN Number: K023302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2024
• Device Model Number: 71344415
• Device Catalogue Number: 71344415
• Device Lot Number: 14CM01567A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR