MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM OX NP LT SZ 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74021164
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during tka surgery, the jrny ii cr lock fem implant impactor did not release the jrny ii cr fem ox np lt sz 4 implant.A back-up device was available and no delay or injury was reported.
Additional Manufacturer Narrative
H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device does not confirm the stated failure mode.The device is covered in bone cement on one side which could link to the connection failure, but is not verifiable.A functional evaluation does not confirm the stated failure mode.After mating the separate devices (as well as a new impactor bumper to replace the broken one), the event in question could not be fully recreated as the event involved wet bone cement and the cement on the device has dried indefinitely.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible probable cause could include but not limited the user error.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: JRNY II CR FEM OX NP LT SZ 4
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10859864
• Report Number: 1020279-2020-06556
• Device Sequence Number: 16794631
• Product Code: JWH
• UDI-Device Identifier: 00885556422793
• UDI-Public: 00885556422793
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2021

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: Health Professional
• Device Model Number: 74021164
• Device Catalogue Number: 74021164
• Device Lot Number: 18BM15587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 08/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1