MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 5-6 RT 9MM; PROSTH, KNEE, PATELLOFEM, SEMI-CONS, CEMENTED, POLY/METAL/POLY

Model Number	74027251
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	01/08/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to severe pain, anastomotic leakage and feeling of illness.
Additional Manufacturer Narrative
The devices, used in treatment were not returned for evaluation, reporting event could not be confirmed.A clinical evaluation was conducted and confirms without the requested clinical information a thorough medical investigation cannot be rendered.Should any additional clinical information be provided this complaint will be re-evaluated.A review of complaint history on the listed parts revealed no prior complaints for the listed batches 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.A review of the risk management file and instructions for use document for this failure mode was conducted.Possible causes could include but not limited to traumatic injury, joint tightness, surgical positioning, material in use, patient reaction or loss of sterility.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 5-6 RT 9MM
• Common Device Name: PROSTH, KNEE, PATELLOFEM, SEMI-CONS, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9652809
• Report Number: 1020279-2020-00422
• Device Sequence Number: 11474166
• Product Code: JWH
• UDI-Device Identifier: 00885556179369
• UDI-Public: 00885556179369
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2020

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: No Information
• Device Model Number: 74027251
• Device Catalogue Number: 74027251
• Device Lot Number: 19BM15456
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 01/31/2020
• Supplement Report FDA Received Date: 05/13/2020
• 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