MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4-RT 11MM; PROSTHESIS, KNEE, PATFEMOROTIBIAL, SEMI-CONSTRAIN, CEMNTD, POLYMR/MET/POLYMR

Catalog Number	74027233
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/13/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, the insert did not seat onto the baseplate well.It looks there is a 0.5mm gap between the insert and baseplate.The doctor confirmed there was no third body or foreign substance, but it did not work well.Finally, a backup size 10mm insert was utilized.This event caused 30 minutes delay of surgery.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device is heavily damaged from attempted use.The device was manufactured in 2019.The medical investigation concluded that, based on the information provided, the root cause of the reported event could not be definitively concluded; although surgical technique/procedure variance could be a potential contributing factor to the reported event.In addition to the reported 30-minute surgical delay, possible patient impact due to the implantation of the unplanned, thinner insert could be subsequent joint laxity, instability, and/or discomfort; however, none could be confirmed based on the information provided.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future the clinical/medical task may be re-evaluated.A dimensional inspection was attempted but the device was too damaged from the attempted insertion to obtain accurate measurements.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 do not have 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 documentation revealed this failure mode was previously identified.Some potential probable causes for this event could include a fit/ sizing issue or a procedural error.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 3-4-RT 11MM
• Common Device Name: PROSTHESIS, KNEE, PATFEMOROTIBIAL, SEMI-CONSTRAIN, CEMNTD, POLYMR/MET/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10129989
• Report Number: 1020279-2020-02159
• Device Sequence Number: 16979796
• Product Code: JWH
• UDI-Device Identifier: 00885556179116
• UDI-Public: 885556179116
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2020

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 Catalogue Number: 74027233
• Device Lot Number: 19JM08921
• Initial Date Received by Manufacturer: 05/14/2020
• Supplement Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 06/08/2020
• Supplement Report FDA Received Date: 09/20/2020
• 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: Required Intervention
• Patient Age: 80 YR