MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN OFFSET COUPLER TRIAL 4MM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71434304

Device Problem Fracture (1260)

Patient Problem Perforation (2001)

Event Date 10/05/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during a tka surgery, the legion offset coupler trial 4mm broke and the stem trail was stuck in the femoral medullary canal.Surgeon created a window by removing the bone chip from the anterior side of the femur to push the stem trial from the proximal part, and removed it from femoral medullary canal and then fixed it with an accord cable.Procedure was delayed for an hour.Current health status of the patient is unknown.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation but the pictures were reviewed, and revealed that coupler broke.The clinical/medical investigation concluded that the provided photos were reviewed; however, with the limited information provided there were no clinical factors found which would have contributed to the broken offset coupler.It was reported the stem trial was removed from the femoral medullary canal by the surgeon creating a window and removing from the anterior femoral side and fixating with an accord cable.The impact to the patient beyond the reported events cannot be determined.A review of complaint history of the previous 12 months revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.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.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.The contribution of the device to the reported incident could be corroborated as it may have occurred due to its extensive use.Based on this investigation, the need for corrective action is not indicated.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: LGN OFFSET COUPLER TRIAL 4MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 15740871
• MDR Text Key: 303137352
• Report Number: 1020279-2022-04707
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010547972
• UDI-Public: 03596010547972
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2022

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: 71434304
• Device Catalogue Number: 71434304
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2022
• Initial Date FDA Received: 11/05/2022
• Supplement Dates Manufacturer Received: 12/01/2022
• Supplement Dates FDA Received: 12/02/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention