MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY II BCS XLPE INSERT; PRSTHESIS,KNEE,PATELLOFMRTIBIL, SMICONSTRAIND, CMNTD, POLYMR/METAL/POLYMR

Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/06/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to infection.The knee poly was removed and no further information is available.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, it has been communicated via email that no relevant supporting clinical information will be provided, and there is no report of the patient's current condition.Therefore based on insufficient information, a clinical assessment cannot be performed at this time.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.We consider this investigation closed.
Event or Problem Description
It was reported a revision surgery to remove the knee poly was performed due to infection.No other devices removed.No further information is available.

• Brand Name: JOURNEY II BCS XLPE INSERT
• Common Device Name: PRSTHESIS,KNEE,PATELLOFMRTIBIL, SMICONSTRAIND, CMNTD, POLYMR/METAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7840937
• Report Number: 1020279-2018-01692
• Device Sequence Number: 1129823
• Product Code: JWH
• UDI-Device Identifier: 00885556179710
• UDI-Public: 00885556179710
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2018

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 09/03/2018
• Supplement Report FDA Received Date: 11/03/2018
• 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