MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR ISRT XLPE RT SZ 1-2 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74025612
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/02/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed due to dislocation.The patient had the mental disorder.The patient fell down and dislocated the insert.The surgeon considered it is not the product failure.The products cannot be returned.No more information is available.Patient fell down due to restlessness caused by delirium, and the patient suffered posterior cruciate ligament injury as a consequence and then insert was dislocated.No more medical information or report was not available because the doctor determined this revision was not caused by the device failure.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, insufficient clinically relevant documentation was provided to perform a thorough medical investigation.However, the patient's mental status (delirium) and traumatic fall was reportedly the initiating factor to the posterior cruciate ligament injury, subsequent insert dislocation, and the revision procedure.The patient impact beyond the reported revision procedure cannot be determined.No further medical assessment can be rendered 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 CR ISRT XLPE RT SZ 1-2 10MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7489254
• Report Number: 1020279-2018-00860
• Device Sequence Number: 144487
• Product Code: JWH
• UDI-Device Identifier: 00885556422731
• UDI-Public: 00885556422731
• 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): 06/20/2018

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: Lay User/Patient
• Device Catalogue Number: 74025612
• Device Lot Number: 17DM17245
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 05/05/2018
• Supplement Report FDA Received Date: 06/20/2018
• 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