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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN RK HK OFFSET COUPLER TRIAL STD 6MM PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

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SMITH & NEPHEW, INC. LGN RK HK OFFSET COUPLER TRIAL STD 6MM PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number 71431911
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/16/2021
Event Type  malfunction  
Event Description
It was reported that, during the set up for a tka surgery, it was noticed the locking mechanism of a lgn rk hk offset coupler trial std 6mm was broken. Surgery was performed, after a non-significant delay, with a back-up device. Since incident occurred before procedure, patient was not involved.
 
Manufacturer Narrative
Internal reference number: case (b)(4).
 
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Brand NameLGN RK HK OFFSET COUPLER TRIAL STD 6MM
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
austin, TX 78735
5123913905
MDR Report Key13157714
MDR Text Key284794280
Report Number1020279-2022-00047
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081111
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71431911
Device Catalogue Number71431911
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received02/03/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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