MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4 LT 10MM; PROSTHESIS, KNEE, PATELLOFEML, SEMI-CONS, CEMENTED, POLY/METAL/POLY

Model Number	74027242
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision surgery due to instability.The insert was exchanged.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A clinical evaluation was conducted and confirms no clinically relevant documentation was provided; therefore, a thorough medical investigation could not be performed.It was reported that approximately 16 months post implantation, the patient required an insert exchange/revision (from a 11mm bcs to 15mm constrained) due to knee laxity.Per communication, ¿ there was no reason to believe they were in any way damaged or faulty¿.The root cause remains unknown.The patient impact beyond the reported laxity and subsequent revision could not be concluded.No further medical assessment is warranted at this time.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.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 poor surgical technique or device selection.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 3-4 LT 10MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEML, SEMI-CONS, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9857704
• Report Number: 1020279-2020-00945
• Device Sequence Number: 11396287
• Product Code: JWH
• UDI-Device Identifier: 00885556177662
• UDI-Public: 00885556177662
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2020

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: 74027242
• Device Catalogue Number: 74027242
• Device Lot Number: 17DM08079
• Initial Date Received by Manufacturer: 06/01/2019
• Supplement Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 04/21/2020
• 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
• Patient Age: 53 YR