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

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).

• Brand Name: LGN RK HK OFFSET COUPLER TRIAL STD 6MM
• 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; austin, TX 78735 ; 5123913905
• MDR Report Key: 13157714
• MDR Text Key: 284794280
• Report Number: 1020279-2022-00047
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081111
• Number of Events Reported: 1
• 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 Received: 01/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 71431911
• Device Catalogue Number: 71431911
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2022
• 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