MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 1-2 LT 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	74027222
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Codes	Unspecified Infection (1930); Osteolysis (2377)
Date of Event	03/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference number: case-(b)(4).
Event or Problem Description
It was reported that, after a tka surgery had been performed on (b)(6) 2020, the patient experienced an infection.A revision surgery was performed on (b)(6) 2021 to treat this adverse event.The jrny ii bcs xlpe art isrt sz 1-2 lt 10mm was explanted; after removing it, scratches/pitting on the articular surface of the medial and lateral side of the implant were noticed.Osteolysis on the medial anterior portion of the tibia and on the distal medial and lateral portion of the femur bone was also noticed during the surgery, but was not seen on the xray.The surgeon made a comment about the surface of the tibial insert and wondered whether that may have been caused by bone cement, however there were no bone cement particles present by looking at the site.The patient outcome is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirmed the stated failure mode.The device has scratches along the medial and lateral surfaces.The device shows signs of prolonged use.A review of sterilization documents indicated that the product was sterilized according to sterilization release documentation.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use document for this failure mode was conducted and concluded this failure mode has been identified.Our clinical/medical team noted: per email correspondence, no clinically relevant documents are available; therefore, a thorough medical assessment cannot be rendered.Should additional information/documentation become available, the clinical/medical task may be re-opened for further evaluation.No medical assessment is warranted at this time.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.Wear potential causes could include but are not limited to friction, joint tightness or patient anatomy.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 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 BCS XLPE ART ISRT SZ 1-2 LT 10MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11713255
• Report Number: 1020279-2021-03347
• Device Sequence Number: 17185645
• Product Code: JWH
• UDI-Device Identifier: 00885556177266
• UDI-Public: 00885556177266
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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): 09/02/2021

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 Model Number: 74027222
• Device Catalogue Number: 74027222
• Device Lot Number: 19EM08983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 09/02/2021
• 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