MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 5-6 RT 9MM; PROSTH,KNEE,PATFEMTIB,SEMCONSTR,CEMNT,POL/METL/POL

Model Number	74027251
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	09/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient suffered from disassembly of the insert.A revision surgery was performed in order to revise the insert and replace it.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device is heavily damaged on the mating surface, which appears to have been caused by disassociation of the device.The clinical/ medical investigation concluded that this case reports a revision was performed due to disassembly of the insert, and the cause is unknown.To date, the requested surgical records and x-rays have not been provided to fully evaluate the root cause of the reported event.The patient impact beyond the revision cannot be determined.No further medical assessment is warranted at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.A dimensional inspection was attempted but the device was too damaged from the disassociation to obtain accurate measurements.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 was previously identified.Some potential probable causes for this event could include a fit/ sizing issue or a procedural 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 BCS XLPE ART ISRT SZ 5-6 RT 9MM
• Common Device Name: PROSTH,KNEE,PATFEMTIB,SEMCONSTR,CEMNT,POL/METL/POL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10618830
• Report Number: 1020279-2020-05082
• Device Sequence Number: 2604020
• Product Code: JWH
• UDI-Device Identifier: 00885556179369
• UDI-Public: 00885556179369
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2021

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: Lay User/Patient
• Device Model Number: 74027251
• Device Catalogue Number: 74027251
• Device Lot Number: 19MM03060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Initial Date Received by Manufacturer: 09/04/2020
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 06/22/2021
• 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