MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN JOURNEY UNI KNEE FEM COMP; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 08/22/2023

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case- (b)(4).

Event Description

It was reported that, after a tka surgery was performed on (b)(6) 2022, the patient experienced painful s/p total knee.The patella was kit resurfaced at the original procedure and was severe grade iv arthritis with large osteophytes around the patella.This adverse event was treated by a revision surgery on (b)(6) 2023, in which a jrny ii isrt xlpe dd lt sz 5-6 10mm was exchanged.Patient's current health status is unknown.

Manufacturer Narrative

H3, h6: the devices were not returned for evaluation; therefore, devices analysis could not be performed.The clinical/medical investigation concluded that, per case details, approximately four (4) months after a total knee arthroplasty surgery was performed, the patient underwent a revision ((b)(6) 2023) and exchange of the jrny ii isrt xlpe dd lt sz 5-6 10mm due to pain.Reportedly, the patient¿s ¿patella was unresurfaced originally and likely a major source of pain.¿ it was further communicated the patient had ¿severe grade iv arthritis,¿ and ¿significant osteophyte formation around her prosthesis, which was removed.¿ per a case communication, ¿there was nothing wrong with the poly, except it needed to be removed to debride the knee and a new one of the same size and thickness was used.¿ reportedly, "it was resurfaced as normal and a 41mm oval patella was utilized.It tracked well." no additional supporting documentation was provided.The patient impact beyond the reported pain and revision with knee debridement and poly insert exchange cannot be determined.The patient¿s current health status is unknown.Device specific identifiers for the femoral component were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, instructions for use, risk management file and prior actions review could not be performed.Device batch number for the insert was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the insert.A review of the instructions for use documents for knee systems provides complete guidelines of indications, contraindications, warnings and precautions and possible adverse effects that may occur preoperative, during surgery or post operative.A review of the risk management file for the insert 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 the part number of the insert and event.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, joint tightness, patient condition or postoperative care.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: UNKN JOURNEY UNI KNEE FEM COMP
• 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: 17730574
• MDR Text Key: 323201784
• Report Number: 1020279-2023-01754
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 00885556098462
• UDI-Public: 00885556098462
• 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
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 10/11/2023
• 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
• Treatment: 74025762, JRNY II ISRT XLPE DD LT SZ 5-6 10MM.
• Patient Outcome(s): Hospitalization; Required Intervention