MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 3-4 RT 9; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 74023231

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Arthralgia (2355); Joint Dislocation (2374)

Event Date 11/17/2023

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that, after right tka surgery had been performed on (b)(6) 2009, the patient experienced symptoms of anterior knee pain in 2023.This adverse event was treated by a revision surgery on an unknown date, to resurface the patella and exchange the poly insert.Upon opening right knee it was found that the ps post of the journ art ins bcs std 3-4 rt 9 was broken.Current health status of patient is unknown.

Event Description

It was reported that, after right tka surgery had been performed on (b)(6) 2009, the patient experienced symptoms of anterior knee pain in november caused by patella wear.This adverse event was treated by a revision surgery on (b)(6) 2023, to resurface the patella and exchange the poly insert.Knee had dislocated and was reduced at base.Upon opening right knee it was found that the ps post of the journ art ins bcs std 3-4 rt 9 was broken.Patient current health status is ok.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation stated that based on the limited information provided the clinical root cause of the reported locked knee, anterior knee pain and dislocation is due the post breakage; however, the clinical root cause of the reported post breakage cannot be definitively concluded.The journ art ins bcs std 3-4 rt 9 remained in vivo for approximately 15 year prior to the total knee arthroplasty revision with exchange of the poly insert and patella resurfacing.The patient impact is the reported ¿locked knee,¿ knee pain, dislocation, and revision.Reportedly, ¿the patient¿s current health status is ok.¿ a review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for knee systems revealed in warnings and precautions that the implant can break or become damaged as a result of strenuous activity or trauma.Additionally, revealed in possible adverse effects that dislocation and subluxation can result from trauma, improper implant selection, improper implant positioning, improper fixation, and/or migration of the components.Muscle and fibrous tissue laxity can also contribute to these conditions.A review of the risk management file revealed this failure mode was previously identified.A review of previous actions concluded that there is a higher than expected risk of revision surgery for the first generation of journey bcs systems.It was recommended to undertake a field safety corrective action to inform surgeons of the higher expected risk of revision, and ensure clear communication that the device should only be used for polyethylene exchange revision of journey bcs total knee constructs where the femoral component and tibial baseplate are well fixed.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include, abnormal loading of limb, excessive forces and/or traumatic injury.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

Manufacturer Narrative

H3, h6: the associated device was returned and evaluated.A visual inspection of the returned explant shows a piece of the post broke off.The piece was returned.The visual also reveals discoloration on the explant.This inspection was conducted by naked eye.The knee insert post deformation and/or fracture may have been due to repeated posterior contact of the femoral cam on the post combined with excessive posterior to anterior shear force during activity.However, this could not be isolated as the root cause for this particular failure mode.Some additional factors that could have contributed to the reported event include patient anatomy, abnormal loading of limb and/or traumatic injury.The clinical/medical investigation stated that based on the limited information provided the clinical root cause of the reported locked knee, anterior knee pain and dislocation is due the post breakage; however, the clinical root cause of the reported post breakage cannot be definitively concluded.The journey articular insert bcs std 3-4 rt 9 remained in vivo for approximately 15 year prior to the total knee arthroplasty revision with exchange of the poly insert and patella resurfacing.The patient impact is the reported ¿locked knee,¿ knee pain, dislocation, and revision.Reportedly, ¿the patient¿s current health status is ok.¿ a review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device over 12 months, however, no commonalities that would suggest a device deficiency was found nor an adverse trend.No similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for knee systems revealed in warnings and precautions that the implant can break or become damaged as a result of strenuous activity or trauma.Additionally, revealed in possible adverse effects that dislocation and subluxation can result from trauma, improper implant selection, improper implant positioning, improper fixation, and/or migration of the components.Muscle and fibrous tissue laxity can also contribute to these conditions.A review of the risk management file revealed this failure mode was previously identified.A review of previous actions concluded that there is a higher than expected risk of revision surgery for the first generation of journey bcs systems.It was recommended to undertake a field safety corrective action to inform surgeons of the higher expected risk of revision, and ensure clear communication that the device should only be used for polyethylene exchange revision of journey bcs total knee constructs where the femoral component and tibial baseplate are well fixed.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include, abnormal loading of limb, excessive forces and/or traumatic injury.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 for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: JOURN ART INS BCS STD 3-4 RT 9
• 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: 18275757
• MDR Text Key: 329846333
• Report Number: 1020279-2023-02410
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 03596010554994
• UDI-Public: 03596010554994
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K042515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2018
• Device Catalogue Number: 74023231
• Device Lot Number: 08DM04823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 12/10/2023; 12/29/2023; 03/22/2024
• Supplement Dates FDA Received: 12/13/2023; 01/02/2024; 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0003-2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization; Required Intervention