MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4 LT 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAIND, CEMNTD, POLY/METAL/POLY

Model Number	74027242
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Codes	Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during total knee arthroplasty the doctor attempted to lock the journey ii articular insert size 3-4 left 9 mm onto the plate tibial base plate nonporus left size 3, but could not locked well.An alternative insert was tried the journey ii articular insert size 3-4 left 10 mm but neither could lock well.Finally the doctor insert the journey ii articular insert size 3-4 left 9 mm by hitting him with a hammer and considered the insert was settled onto the base plate.There was a 40 minute delay for this event.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device has signs of damage from attempted use.The device was manufactured in 2020.The clinical / medical investigation concluded that, based on the limited information provided, the root cause of the reported event could not be concluded.The surgical technique does note, however, that the bcs articulating component can be difficult to insert and provides recommendations.The patient impact beyond the reported 40- minute surgical extension and modified surgical procedure could not be determined, as it was reported that after the failed 10mm insert attempt, the procedure was completed by hitting the initially attempted 9mm insert with a hammer to seat the articulating insert onto the tibial baseplate with no serious injury.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A dimensional inspection was attempted but the device was too damaged from the attempted insertion 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 3-4 LT 10MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAIND, CEMNTD, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10657744
• Report Number: 1020279-2020-05307
• Device Sequence Number: 11442972
• Product Code: JWH
• UDI-Device Identifier: 00885556177662
• UDI-Public: 00885556177662
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2021

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: 74027242
• Device Catalogue Number: 74027242
• Device Lot Number: 20AM17757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 01/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TIBIA BASE 74022223, LOT 20CM00469; TIBIA BASE 74022223, LOT 20CM00469
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 60