MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN OFFSET COUPLER TRIAL 6MM; PROSTHESIS, KN, FMOROTIBIAL, SEMI-CONSTRAIND, CEMENTED, MTAL/POLYMR

Model Number 71434306

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 01/17/2020

Event Type  Injury  

Event Description

It was reported that during an s+n knee revision the coupler broke as the surgeon was taking the trial femoral component out of the patient.No pieces were left into the patient.No injuries or delays reported.A backup device was available.

Manufacturer Narrative

Additional information: e1 the device, used in treatment was not returned for evaluation, reporting event could not be confirmed.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: LGN OFFSET COUPLER TRIAL 6MM
• Type of Device: PROSTHESIS, KN, FMOROTIBIAL, SEMI-CONSTRAIND, CEMENTED, MTAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9656955
• MDR Text Key: 177349504
• Report Number: 1020279-2020-00433
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010547989
• UDI-Public: 03596010547989
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/01/2020

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: 71434306
• Device Catalogue Number: 71434306
• Device Lot Number: 06CM17133
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/17/2020
• Initial Date FDA Received: 02/02/2020
• Supplement Dates Manufacturer Received: 01/17/2020
• Supplement Dates FDA Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1