MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR ISRT XLPE LT SZ 1-2 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number 74025621

Device Problem Degraded (1153)

Patient Problems Failure of Implant (1924); Foreign Body In Patient (2687)

Event Date 05/26/2022

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) 2022, the patient experienced severe wear of the insert.This adverse event was addressed by revision surgery to explant the jrny ii cr isrt xlpe lt sz 1-2 9mm, jrny ii cr fem ox np lt sz 4, journey tibia base np lt sz 2 and gen ii 7.5mm resur pat 26mm.Patient current health status is unknown.

Manufacturer Narrative

The device was not returned for evaluation but the pictures were reviewed, and the severe wear of the insert was confirmed.The clinical/medical investigation concluded that the two undated, unlabeled x-rays support the report and the metal-on-metal contact of the femoral and tibial components.However, the definitive clinical root cause of the severe wear reported cannot be fully assessed based on the information available.Although, we cannot rule out poor bone quality due to patient¿s age as a likely contributory factor.Based on the information provided, the patient was revised to address this issue.Consequently, the patient¿s current health status is unknown.Therefore, the impact to the patient beyond that which has already been reported cannot be confirmed nor concluded.Should any additional relevant medical information be provided, this cause would be re-assessed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for knee systems revealed in possible adverse effects that wear of the polyethylene articulating surfaces of knee replacement components has been reported following total knee replacement.Higher rates of wear may be initiated by particles of cement, metal, or other debris which can cause abrasion of the articulating surfaces.Higher rates of wear may shorten the useful life of the prosthesis, and lead to early revision surgery to replace the worn prosthetic components.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Potential causes could include but are not limited to friction, joint tightness or lifetime of device.The contribution of the device to the reported event could could be corroborated as the device was damaged and it was required a revision surgery to treat this event.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.

• Brand Name: JRNY II CR ISRT XLPE LT SZ 1-2 9MM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• 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: 14655037
• MDR Text Key: 294853291
• Report Number: 1020279-2022-02865
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556422670
• UDI-Public: 00885556422670
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K121443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 74025621
• Device Catalogue Number: 74025621
• Device Lot Number: 18FM06310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2022
• Date Device Manufactured: 06/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 71932634; 74021164; 74022222
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 56 KG