MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN JOURNEY BCS KNEE INSERT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number UNKNOWN

Device Problem Fracture (1260)

Patient Problems Foreign Body Reaction (1868); Failure of Implant (1924); Discomfort (2330); Joint Laxity (4526)

Event Date 06/22/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after a tka procedure had been performed on (b)(6) 2008, the patient experienced peg breakage.This adverse event was addressed by revision surgery on (b)(6) 2022 to exchange the unknown journey bcs knee insert.Patient's current health status is unknown.

Manufacturer Narrative

H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device was found to be fractured along the post, rendering the device inoperative.The fractured post component was returned with the device.The clinical medical evaluation concluded that based on the documentation provided, the root cause of the reported event could not be definitively concluded; although the length of time in-vivo with age-related wear and a noted pre-op ¿mild collateral ligament loosening¿ could not be ruled out as potential contributing factors.It is unknown if the patient experienced any trauma or strenuous activity prior to the onset of symptoms.The knee systems information for use (ifu) document addresses device limitations and finite expected service life.The patient impact beyond the reported symptoms, instability and revision could not be determined.The current patient status is unknown.No further medical assessment can be rendered at this time.Due to the damage along the base of the device, the product number and product batch number could not be found.Therefore, a thorough product history review could not be conducted.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 contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.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.We consider this investigation closed.Internal complaint reference number: (b)(4).

• Brand Name: UNKNOWN JOURNEY BCS KNEE INSERT
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: 15047865
• MDR Text Key: 296131709
• Report Number: 1020279-2022-03322
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Required Intervention