MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HK 11MM BOLT - SLEEVE; PROSTHSIS, KNE, FEMOROTIBIAL, CONSTRAIND, CMNTD, METAL/POLYMR

Model Number 71421385

Device Problem Defective Component (2292)

Patient Problem Injury (2348)

Event Date 10/18/2019

Event Type  Injury  

Event Description

It was reported that during a revision surgery (not confirmed that the revision surgery is from smith and nephew), while assembling the implants, the screw could not be attached to the tibial component.After multiple attempts and a delay of 2 hours the doctor decided to close the patient to avoid any exposure to more anesthesia.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical / medical investigation concluded that no clinical/medical documentation has been provided to support the complaint at this time.Without supporting clinical/medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes of the reported event could include device damaged or out of specification.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 warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: LEGION HK 11MM BOLT - SLEEVE
• Type of Device: PROSTHSIS, KNE, FEMOROTIBIAL, CONSTRAIND, CMNTD, METAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9331678
• MDR Text Key: 166741851
• Report Number: 1020279-2019-04064
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00885556029213
• UDI-Public: 00885556029213
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/07/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 71421385
• Device Catalogue Number: 71421385
• Device Lot Number: 19DTM0011A
• Initial Date Manufacturer Received: 10/18/2019
• Initial Date FDA Received: 11/15/2019
• Supplement Dates Manufacturer Received: 02/03/2020
• Supplement Dates FDA Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1