MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM OX NP LT SZ 6; PROSTH, KNEE, PATELLOFEM, SEMI-CONS, CEMENTED, POLY/METAL/POLY

Model Number	74021166
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Irregular Pulse (2469); Heart Block (4444)
Date of Event	12/31/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during tka procedure patient had episode of third degree heart block.Heart rate dropped to 10.The procedure was stopped.The crash cart was brought in the room, and the code team activated.No compression required, medication administered per anesthesia.Hospitalization was prolonged as a result of the event.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, this complaint from the united states journey ii retrospective study reports an episode of third degree heart block during the primary surgery.It was reported that during total knee arthroplasty procedure the patient had episode of third degree heart block.The heart rate dropped to 10.The procedure stopped.Crash cart brought in room, and the code team activated.No compressions were required, medication administered per anesthesia.The impact to the patient was the hospitalization was prolonged as a result of the event.The clinical study report forms were provided for review and only suggested that the cardiac issue was precipitated by the stress of surgery.Smith and nephew has not received adequate materials (operative reports from the surgeon) to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.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 did not reveal additional complaints for the listed batch.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to procedural/user error, surgical complication or patient medical history.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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 FEM OX NP LT SZ 6
• Common Device Name: PROSTH, KNEE, PATELLOFEM, SEMI-CONS, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10421081
• Report Number: 1020279-2020-04005
• Device Sequence Number: 11510896
• Product Code: JWH
• UDI-Device Identifier: 00885556422779
• UDI-Public: 00885556422779
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2021

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 Model Number: 74021166
• Device Catalogue Number: 74021166
• Device Lot Number: 13AM06737
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention