MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR ISRT XLPE RT SZ 3-4 10MM; PRSTHSIS,KNEE,PTLLOFMRTIBL,SMI-CNSTRND,CMNTD,PLYMR/MTAL/POLYMR

Catalog Number	74025632
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/22/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to infection.The insert was replaced to new one.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, insufficient clinically relevant documentation was provided; therefore a thorough medical investigation cannot be performed.However, it was communicated that the revision/insert exchange was performed due to infection just 11 days post implantation and that the surgeon did not fault the device.The patient impact beyond probable antibiotic therapy and the revision itself cannot be determined.No further medical assessment is warranted at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the part revealed no prior complaints for the listed batch.Product was sterilized according to sterilization release documentation from quality control.Without the actual product involved and/or device information 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.Credit cannot be issued for this device.

• Brand Name: JRNY II CR ISRT XLPE RT SZ 3-4 10MM
• Common Device Name: PRSTHSIS,KNEE,PTLLOFMRTIBL,SMI-CNSTRND,CMNTD,PLYMR/MTAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7715133
• Report Number: 1020279-2018-01372
• Device Sequence Number: 16314669
• Product Code: JWH
• UDI-Device Identifier: 00885556422595
• UDI-Public: 00885556422595
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 09/11/2018

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
• Device Expiration Date: 04/20/2026
• Device Catalogue Number: 74025632
• Device Lot Number: 16DM16637
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 09/11/2018
• 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: Other; Required Intervention