MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 5-6 RT 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74027251
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a tka surgery had been performed on (b)(6) 2021, the patient experienced pain.During the primary surgery, the patella was not resurfaced.To address this adverse event, a revision surgery was performed on (b)(6) 2024, during which the patella was resurfaced, and one (1) jrny ii bcs xlpe art isrt sz 5-6 rt 9mm was exchanged for a 10mm insert.The patient's current health status is unknown.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.The visual inspection revealed that the jrny ii bcs xlpe art isrt sz 5-6 rt 9mm was returned in one piece, albeit naturally worn.The implant shows signs of extensive wear and use.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 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 previous actions concluded that there is a higher than expected risk of revision surgery when the patella is unresurfaced at the index surgery.Patella resurfacing is an intraoperative discretionary decision of the surgeon, and this clinical decision may mitigate risk for individual patients.Actions were taken to update the instructions for use document and surgical technique to include statements informing users that outcome data reported in some registries suggest that resurfacing the patella during primary total knee arthroplasty should be considered since it may decrease the rate of revision, provided the patient¿s anatomical and clinical conditions allow.It also reveals in the indications, contraindications, and adverse effects section that the preoperative planning and meticulous surgical technique are essential to achieve optimum results.Considerations of anatomic loading, soft-tissue condition, and component placement are critical to minimize a variety of postoperative complications.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.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: JRNY II BCS XLPE ART ISRT SZ 5-6 RT 9MM
• Common Device Name: 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: 19515547
• Report Number: 1020279-2024-01129
• Device Sequence Number: 3340465
• Product Code: JWH
• UDI-Device Identifier: 00885556179369
• UDI-Public: 00885556179369
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 74027251
• Device Lot Number: 21AM03258
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2024
• Supplement Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 07/11/2024
• Date Device Manufactured: 01/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown