MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ECH POR STD 260MM BOW SZ 12 L; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 71340412

Device Problem Material Twisted/Bent (2981)

Patient Problem Failure of Implant (1924)

Event Date 01/15/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case-(b)(4).

Event Description

It was reported that, after a primary left total hip arthroplasty had been performed, the patient fell down and experienced a vancouver type b3 periprosthetic fracture.Therefore, a revision surgery was performed in order to solve this adverse event, and it was found that the acetabular component was stable, but the femoral component was revised with an echelon 260mm porous bowed femoral component standard collar size 12 left.On sixth week control, it was found on x-rays that the echelon 260mm porous bowed femoral stem is bending.It is unknown if any intervention has been performed.It is unknown if a second revision surgery has been scheduled.The current health status of patient is unknown.

Manufacturer Narrative

The device is still implanted, therefore it has not been returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, smith and nephew has not received the explanted device and/or adequate materials to fully evaluate the complaint.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review of the instructions for use for this device revealed that bending has been identified in adverse events in primary and revision surgery.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or potential causes that could contribute to the reported event include excessive forces applied to implant, traumatic injury and surgical technique.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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: ECH POR STD 260MM BOW SZ 12 L
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 13499022
• MDR Text Key: 285349113
• Report Number: 1020279-2022-00600
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010383945
• UDI-Public: 03596010383945
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K983834
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/07/2022

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
• Device Operator: Health Professional
• Device Model Number: 71340412
• Device Catalogue Number: 71340412
• Device Lot Number: 18EM08078A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2022
• Initial Date FDA Received: 02/09/2022
• Supplement Dates Manufacturer Received: 03/21/2022
• Supplement Dates FDA Received: 04/07/2022
• Date Device Manufactured: 05/09/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Female