MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEM COCR LT SZ 3; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74024923
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a bilateral tka was performed on (b)(6) 2019.First, the right knee was implanted.After the implantation of right knee, the doctor found the product for left knee has been implanted into right knee.Left knee tka was performed accordingly.The doctor does not confirm it product failure.No delay was reported.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded; no relevant clinical medical information was provided to conduct a thorough medical assessment.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 BCS II FEM COCR LT SZ 3
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8306775
• Report Number: 1020279-2019-00452
• Device Sequence Number: 11178431
• Product Code: JWH
• UDI-Device Identifier: 00885556170311
• UDI-Public: 00885556170311
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: JA
• 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): 06/23/2019

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: Health Professional
• Device Catalogue Number: 74024923
• Device Lot Number: A1801843
• Initial Date Received by Manufacturer: 01/15/2019
• Supplement Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 06/23/2019
• 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
• Patient Age: 80 YR