MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 1-2 RT 11MM; PR, KNEE, PTLLFMRTIBIAL, SMI-CNSTRD, CMNTD, PLYMR/MTL/PLYMR

Model Number	74027213
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the insert cannot be inserted fully onto the baseplate.The insert was sliding onto the baseplate, a resistance was felt by the surgeon and it didn't feel smooth, the anterior side of the insert was not sat fully onto the baseplate, also it was not fit or locked.It caused 10 minutes delay of surgery.An alternative device, s&n 12mm insert, was used to finish the surgery.No injury reported nor additional bone cuts were required.
Additional Manufacturer Narrative
Smith & nephew, inc.Is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based upon information which smith & nephew, inc.Has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, inc., or its employees, that the report constitutes an admission that the device, smith & nephew, inc., or its employees caused or contributed to the potential event described in this report.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 1-2 RT 11MM
• Common Device Name: PR, KNEE, PTLLFMRTIBIAL, SMI-CNSTRD, CMNTD, PLYMR/MTL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9921364
• Report Number: 1020279-2020-01132
• Device Sequence Number: 11606794
• Product Code: JWH
• UDI-Device Identifier: 00885556178768
• UDI-Public: 00885556178768
• Combination Product (Y/N): N
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 74027213
• Device Catalogue Number: 74027213
• Device Lot Number: 18GM18806
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 06/12/2020
• Patient Sequence Number: 1
• Patient Age: 76 YR