MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN OX CONSTRAIN FEM TRL 6 RT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 71431176

Device Problem Fracture (1260)

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

Event Date 03/29/2024

Event Type  malfunction  

Manufacturer Narrative

Internal reference number: (b)(4).

Event Description

It was reported that during a tka, the g2 ins spac tr sz5-6 15mm shim cracked while trialing.Additional, the lgn dis fem wdg trl 5mm sz 6 broke off inside the lgn ox constrain fem trl 6 rt.The procedure was resumed, without any delay, using the same device.Patient was not harmed as consequence of this problem.

• Brand Name: LGN OX CONSTRAIN FEM TRL 6 RT
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-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: 19197456
• MDR Text Key: 341280068
• Report Number: 1020279-2024-00841
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010545480
• UDI-Public: 03596010545480
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 71431176
• Device Lot Number: 07FM15582
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2007
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1