MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II XR BASEPLATE SZ 6 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74022206
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/30/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with recent xr implant (surgery (b)(6) 2018) returned with complaints of knee pain.Upon x-ray review with doctor, it appeared that the patient's patella has rotated vertically.Doctor mentioned that he believed the incident and lack of patella tracking to be associated with the xr tibial baseplate, although he was not sure.The patient has been scheduled to have their patella resurfaced, original primary xr tka components are not planned to be replaced as there was no mention of issues with the components themselves being faulty.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, no relevant supporting clinical information has been provided to assist with a clinical investigation, and the patient's current condition is unknown.Therefore based on insufficient information, a thorough clinical assessment cannot be performed 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 listed part revealed no prior complaints for the listed batch.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.

• Brand Name: JRNY II XR BASEPLATE SZ 6 LT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; memphis TN
• MDR Report Key: 7911059
• Report Number: 1020279-2018-01856
• Device Sequence Number: 19262979
• Product Code: JWH
• UDI-Device Identifier: 00885556615362
• UDI-Public: 00885556615362
• Combination Product (Y/N): N
• PMA/510(K) Number: K152726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2019

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 Catalogue Number: 74022206
• Device Lot Number: 17DSL0004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2018
• Supplement Report FDA Received Date: 03/22/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization