MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HK 4.75 HEX TORQUE WRENCH ADAPT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71434487

Device Problems Material Deformation (2976); Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 09/14/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, after total knee arthroplasty was performed on an unspecified date, a revision surgery was conducted on (b)(6) 2021 due to implant wear.During revision, it was observed that a legion hinge 4.75mm hex torque wrench adaptor was stripped under normal wear and tear.Surgery was resumed, without any delay, with a smith & nephew back-up device.Patient current health status is unknown.

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, this case reports a revision of a competitor prosthesis after a total knee arthroplasty due to implant wear and the adaptor was reportedly ¿stripped under normal wear and tear.¿ the procedure was reportedly completed with a backup smith and nephew device without a surgical delay.The date of the primary surgery was not provided.No additional clinically relevant supporting information has been provided to assist with the clinical investigation.The patient is reportedly ¿doing well.¿ the patient impact beyond the use of a back-up device could not be determined.No further clinical assessment can be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A complaint history review found related failures for the listed batch; 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.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 probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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.

Manufacturer Narrative

After further assessment of the information gathered by the manufacturer, it was identified that this event should be re-evaluated for mdr reporting.The original information stated that, during a revision surgery of a non-s+n device, it was observed that a legion hinge 4.75mm hex torque wrench adaptor was stripped due to normal wear and tear.Surgery was resumed, without any delay, using a smith & nephew back-up device.Patient was not harmed as a consequence of this issue.However, after further clarification and information received, it was determined that the issue does not meet the criteria to be reportable, since patient was not injured and if the device¿s malfunction were to recur, it would not be likely to cause or contribute to a death or serious injury.

Event Description

It was reported that, during a revision surgery of a non-s+n device, it was observed that a legion hinge 4.75mm hex torque wrench adaptor was stripped due to normal wear and tear.Surgery was resumed, without any delay, using a smith & nephew back-up device.Patient was not harmed as a consequence of this issue.

• Brand Name: LEGION HK 4.75 HEX TORQUE WRENCH ADAPT
• 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
• MDR Report Key: 12619440
• MDR Text Key: 276095055
• Report Number: 1020279-2021-07545
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 00885556488454
• UDI-Public: 00885556488454
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 71434487
• Device Catalogue Number: 71434487
• Device Lot Number: 12FAB0012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2012
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention