MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 7-8 RT 9MM; PRSTHSS,KNE,PTLLOFMRTIBL,SMI-CNSTRND,CMNTDPLYMRMTALPLYMR

Model Number	74027271
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed, patient had a clicking noise while taking the knee through a range of motion two days after surgery.Dr.Claps brought the patient back and opened the knee to find out that the back of the post was damaged and it was hitting up against a ridge of bone inside of the box of the femur.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.A visual inspection of the picture provided confirmed the stated failure mode.The post on the device is damaged.The medical investigation concluded that, although two photo images of the explanted liner were submitted, they did not provide insight into the root cause of the reported event.Without clinically relevant supporting documentation and/or the explant return/evaluation, the root cause of the reported clicking during rom and subsequent revision 2 days post implantation could not be definitively concluded.However, it was reportedly noted during the revision that the ¿back of the post was damaged and hitting up against a ridge of bone inside of the box of the femur.¿ the patient impact beyond the reported liner damage and revision just 2 days post implantation could not be determined.No further medical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Some potential probable causes of this event could include abnormal loading or alignment.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 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 7-8 RT 9MM
• Common Device Name: PRSTHSS,KNE,PTLLOFMRTIBL,SMI-CNSTRND,CMNTDPLYMRMTALPLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9516210
• Report Number: 1020279-2019-04578
• Device Sequence Number: 11613714
• Product Code: JWH
• UDI-Device Identifier: 00885556179710
• UDI-Public: 00885556179710
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2020

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: 74027271
• Device Catalogue Number: 74027271
• Device Lot Number: 18DM12624
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 12/24/2019
• Supplement Report FDA Received Date: 03/17/2020
• 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; Required Intervention