MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HK 11MM BOLT - SLEEVE PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71421385

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4). Initial reporter postal code: (b)(6).

Event Description

It was reported that, during a revision surgery, both lugs of 2 legion hk 11mm bolt - sleeve broke off in situ. On the 1st attempt at sleeve placement, the sleeve was apparently correctly positioned. The bolt screw could be tightened with the screwdriver. The torque wrench was then used. The bolt screw could be turned freely through 360°. Then there was an explantation of the bolt and metal sleeve. The metal pin on the metal sleeve was broken off. On the second attempt to set the sleeve, the sleeve was apparently correctly positioned. The bolt screw could be tightened with the screwdriver. The torque wrench was then used. The bolt screw could be turned freely through 360°. Then there was an explantation of the bolt and metal sleeve. The metal pin on the metal sleeve was broken off. Finally, on the third attempt with third new sleeve, this time the torque was deliberately omitted, because if it had been repeated again, there would have been no alternative. Surgery was not delayed. Patient was not harmed.

• Brand Name: LEGION HK 11MM BOLT - SLEEVE
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, 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 ; 5123913905
• MDR Report Key: 12714943
• MDR Text Key: 279058962
• Report Number: 1020279-2021-07714
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K081111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 71421385
• Device Catalogue Number: 71421385
• Device Lot Number: 19DTM0011A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/28/2021 Patient Sequence Number: 1