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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. LEGION HK 11MM BOLT - SLEEVE PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
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.
 
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Brand NameLEGION HK 11MM BOLT - SLEEVE
Type of DevicePROSTHESIS, 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 Key12714943
MDR Text Key279058962
Report Number1020279-2021-07714
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K081111
Number of Events Reported1
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 Received10/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71421385
Device Catalogue Number71421385
Device Lot Number19DTM0011A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/05/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/08/2019
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
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