MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4 LT 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74027243
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Date of Event	05/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka was performed on (b)(6) 2021, the patient experienced pain and dislocation.A revision surgery was performed on (b)(6) 2021 to treat these adverse events.Details about the surgery are unknown but the surgeon reported that the devices implanted were not defective.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 subsequent e-mail, neither the requested clinical information or the device will be provided for evaluations.Therefore, a thorough medical investigation cannot be rendered nor can a root cause of the reported pain and dislocation be determined.Based on the information provided, the surgeon performed a revision to treat the adverse events.Although the details of the revision surgery were not provided, it was reported by the surgeon the devices were not defective.The impact to the patient beyond that which has already been reported cannot be determined.Should any additional relevant medical information be provided, this complaint will be re-assessed.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.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.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.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 3-4 LT 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11977302
• Report Number: 1020279-2021-05111
• Device Sequence Number: 3388842
• Product Code: JWH
• UDI-Device Identifier: 00885556177716
• UDI-Public: 00885556177716
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K11711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 74027243
• Device Catalogue Number: 74027243
• Device Lot Number: 20HM16134
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 08/20/2021
• 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: Required Intervention