MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HK GM TIB ISRT TRL 11MM SZ 4-5 RT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	71434542
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery the surgeon believed the trial component parts were adequately locked together during a trial reduction.Later determined they were not, resulting in the need for 5mm femoral augments.Final poly insert implant was also exchanged for a larger size.Less than 30 minutes delay was reported and a backup device was available.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and the incomplete threading of the post into the trial tibia was reportedly the root cause of the additional 5mm distal femoral cut, subsequent augments, up-sized insert and slight surgical extension.Based on communication that the surgeon ¿does not feel this affected the patient¿ and no patient injury resulted from the slight surgical extension, no further patient impact is anticipated.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.We consider this investigation closed.

• Brand Name: LEGION HK GM TIB ISRT TRL 11MM SZ 4-5 RT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8791759
• Report Number: 1020279-2019-02690
• Device Sequence Number: 1977950
• Product Code: LXH
• UDI-Device Identifier: 00885556259009
• UDI-Public: 00885556259009
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 71434542
• Initial Date Received by Manufacturer: 06/17/2019
• Supplement Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 07/15/2019
• Supplement Report FDA Received Date: 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention