MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 5-6 LT 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74027263
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, there was a post broke on a journey ii bcs xlpe art insert size 5-6 left 11mm.Incident occurred while patient was painting (kneeling and walking on his knees).There was a poly swap.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.The lab analysis concluded that the post of the tibial insert fractured.The articulating surface of the tibial insert showed signs of discoloration and deformation.Discoloration was likely due to the absorption of lipids.Deformation was likely due to contact of the femoral component with the tibial insert.The insert also showed signs of deformation around the lock detail, superior surface, and the inferior surface of the insert.This deformation was likely due to the removal of the tibial insert.This examination also showed deformation of the posterior side of the post.This was likely due to contact with the femoral cam.The causes of the deformation along the anterior side of the post and the fracture of the post could not be determined from this investigation.No material or manufacturing deviations were observed during the investigation of this device.The clinical/medical evaluation concluded that this case reports a revision was performed to exchange the poly insert was performed due to a broken post that occurred while the patient was kneeling and walking on his knees.Per email communication, the requested surgical report and x-rays are not available.Therefore, the patient impact beyond the revision cannot be determined.Due to the limited information provided, no further clinical assessment is warranted.Should additional clinically relevant documentation become available, the clinical/medical task may be re-opened.A review of complaint history did not reveal additional complaints for the listed batch.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.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.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 future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 5-6 LT 11MM
• 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: 11077532
• Report Number: 1020279-2020-07825
• Device Sequence Number: 14196744
• Product Code: JWH
• UDI-Device Identifier: 00885556178065
• UDI-Public: 00885556178065
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2021

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 Expiration Date: 02/14/2023
• Device Model Number: 74027263
• Device Catalogue Number: 74027263
• Device Lot Number: 13BM09300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 09/09/2021
• 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: 71 YR