MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 1-2 RT 9MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	74027211
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	05/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a knee surgery had been performed on (b)(6) 2019, the patient experienced joint laxity that was addressed via revision surgery on (b)(6) 2021.A jrny ii bcs xlpe art isrt sz 1-2 rt 9mm was explanted.In addition, a jrny ii bcs cnstrd art isrt 1-2 rt 13m and a jrny bcs pat resrf rd 29 mm std were implanted.The patient outcome is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, the patient required an insert revision approximately 2 years post implantation due to laxity.Reportedly, the patella was also resurfaced during this procedure, as it was not performed during the primary tka, and does not represent a mal-performance of any tka component.Responses to the clinical documentation/information requests were not provided.Based on the limited information, the root cause of the reported laxity and subsequent insert revision could not be determined.Patient impact beyond the reported laxity and revision could not be fully assessed.No further medical assessment could be rendered at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.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.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as abnormal motion over time, bone degeneration, fit/sizing issue, lack of ingrowth, lifetime of device, and/or traumatic injury.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 BCS XLPE ART ISRT SZ 1-2 RT 9MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11860339
• Report Number: 1020279-2021-04554
• Device Sequence Number: 4043333
• Product Code: JWH
• UDI-Device Identifier: 00885556178669
• UDI-Public: 00885556178669
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2021

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: 74027211
• Device Catalogue Number: 74027211
• Device Lot Number: 18KM15400
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 08/30/2021
• 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; Other; Required Intervention