MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TIB BASE SZ 3 LM/RL; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 00584200301

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Discomfort (2330)

Event Date 11/24/2021

Event Type  Injury  

Event Description

It was reported that, after an uka on (b)(6) 2021 performed 8 years ago, while getting out of the truck, the patient felt something.It was determined that the tib base sz 3 lm/rl fractured.A revision surgery was performed on (b)(6) 2021 to remove all the implants.The current health status of patient is unknown.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The wall of the baseplate fractured off.The fractured component was not returned with the assembly.The device is covered bone cement.A review of complaint history did not reveal similar events for the listed device.The clinical/medical evaluation concluded that based on the information provided, the root cause of the reported unspecified patient symptoms, ¿the patient felt something while getting out of the truck,¿ and tibia baseplate fracture, cannot be definitively concluded.The patient¿s current health status remains unknown.The patient impact beyond the reported unspecified symptoms, component wall-fracture and revision cannot be determined, and no further medical assessment can be rendered.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.Some potential probable causes for this event could include but not limited to traumatic injury, surgical technique or implant failure.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.Additional information: d3, d4, d8/d9 and h4/h5.

• Brand Name: TIB BASE SZ 3 LM/RL
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-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: 13002721
• MDR Text Key: 282220158
• Report Number: 1020279-2021-08660
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00885556619759
• UDI-Public: 00885556619759
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: 00584200301
• Device Catalogue Number: 00584200301
• Device Lot Number: 60718019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1