MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR ISRT XLPE LT SZ 1-2 9MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74025621
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/02/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after the surgery the patient felt the uncomfortableness.X-ray showed posterior subluxation of the femoral component.So the insert was revised.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A lab analysis was conducted and the components were inspected visually to determine the cause of the reported incident.No destructive analysis was conducted during this investigation.The insert was worn with scratches on the articulating and non-articulating surfaces.The periphery of the locking detail has some damage.There were no observations of material or manufacturing deviations in the course of this investigation.A clinical evaluation was conducted and without the request clinical information a thorough medical investigation cannot be rendered.Should any additional medical information be provided this complaint will be re-assessed.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.There were no observations of material or manufacturing deviations in the course of this investigation.Should information become available this complaint can be re-assessed.Available this complaint can be re-assessed.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: JRNY II CR ISRT XLPE LT SZ 1-2 9MM
• 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: 8834669
• Report Number: 1020279-2019-02802
• Device Sequence Number: 10819497
• Product Code: JWH
• UDI-Device Identifier: 00885556422670
• UDI-Public: 00885556422670
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• 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): 11/19/2019

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: 74025621
• Device Lot Number: 17EM15463
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 07/28/2019
• Supplement Report FDA Received Date: 11/19/2019
• 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