MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 1-2 RT 10MM; PROSTHSIS KNEE PATELLOFEMOROTIBIAL SEMCONSTRAIND CMNTD METAL/POLYMER

Catalog Number	74027212
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/24/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the insert could not be connected to the baseplate.The surgeon tried to insert several time.It seems that the locking area deformed.Please perform dimensional inspection.40 minutes delay was reported.The surgery was completed with a backup 11mm insert.No patient injury was reported.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A review of the manufacturing records did not reveal any material or manufacturing deviations that caused or contributed to the reported incident.A dimensional evaluation was attempted; however, damage at several features of the device would not allow for accurate measurement.The features that could be measured were found to print specification.A lab analysis indicated that damage seen on the inferior surface of the insert caused by third-body particulate (bone fragment) getting lodged between the baseplate and insert during insertion.The deformation of the insertion divots resulted from the force of the insertion tool pressing on them during insertion while full seating of the insert was impeded by a third-body particulate; making fully seating the insert difficult.Deformation of the lateral side of the posterior locking mechanism resulted from the surface pressing against the lock detail of the baseplate, rather than fitting under it, or by pressing against a foreign object.A clinical analysis indicated that it was reported that there was a 40 minute surgical delay due to the poly insert not locking into the baseplate.The surgery was completed with a backup insert, and no patient injury was reported.Therefore, no further clinical assessment is warranted.A review of complaint history on the listed part revealed no additional complaints for the listed batch with this failure mode.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.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 1-2 RT 10MM
• Common Device Name: PROSTHSIS KNEE PATELLOFEMOROTIBIAL SEMCONSTRAIND CMNTD METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7066139
• Report Number: 1020279-2017-01136
• Device Sequence Number: 10802066
• Product Code: JWH
• UDI-Device Identifier: 00885556178713
• UDI-Public: 00885556178713
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2018

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: No Information
• Device Catalogue Number: 74027212
• Device Lot Number: 16EM21575
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/24/2017
• Supplement Date Received by Manufacturer: 11/24/2017
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 04/04/2018
• 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