MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HK TIBIAL BASE SZ 5 LT; TOTAL KNEE JOINT

Catalog Number 71421305

Device Problem Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 10/07/2015

Event Type  Injury  

Manufacturer Narrative

Customer indicated that there is no product/device to be returned for investigation analysis.

Event Description

It was reported that a surgery was delayed 90 minutes due to a positioning issue with the implant.After it was noticed the implant was not positioned correctly, the implant was removed, cleaned, and re-implanted during the surgery.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The associated device was not returned for evaluation.Our product development team was notified of this complaint.The base plate in question does have laser markings intended to be used to mitigate this failure mode.If followed properly, the existing surgical technique itemizes how to ensure proper rotation of this system.A review of complaint history did not reveal any previous complaints for this device/failure mode.No additional actions are being taken at this time.

• Brand Name: LEGION HK TIBIAL BASE SZ 5 LT
• Type of Device: TOTAL KNEE JOINT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: robert rust ; 1450 brooks road; memphis, TN 38116 ; 9013991624
• MDR Report Key: 5182050
• MDR Text Key: 29415065
• Report Number: 1020279-2015-00743
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K081111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71421305
• Device Lot Number: 13JBP0124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 75 YR
• Patient Weight: 95