MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 7-8 RT 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CNSTRND, CEMENTED, POLY/METAL/POLY

Model Number	74027273
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Failure of Implant (1924); Muscle/Tendon Damage (4532)
Date of Event	02/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, a revision surgery was required to change a journey ii bcs xlpe art insert size 7-8 rt 11mm due to mechanical failure.The patient suffered a rupture of the retinacular mechanism.The old poly was exchanged by a journey ii constrained insert.No other complications were reported.No patient information or operative reports are available.The patient's current status is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection of the rny ii bcs xlpe art isrt sz 7-8 rt 11mm shows scratches at the locking point, which could cause the device not to function properly.The clinical/medical team concluded, this case reports the revision of a journey ii bcs xlpe articulating insert to a journey ii constrained insert due to the rupture of the retinacular mechanism.Per email correspondence, the requested operative reports and x-rays are not available, and the current patient status is also unknown.Therefore, a no further medical assessment can be rendered, and the clinical root cause of the ruptured retinacular mechanism cannot be determined.Should additional clinically relevant documentation become available, the clinical/medical task may be re-evaluated.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 have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A review of complaint history for the listed parts revealed no prior complaints for the listed batch.A review of risk management files and instructions for use found that the reported failure was documented appropriately.A dimensional inspection was attempted but the device was too damaged from the attempted insertion to obtain accurate measurements.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.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 7-8 RT 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CNSTRND, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11427093
• Report Number: 1020279-2021-01823
• Device Sequence Number: 2964857
• Product Code: JWH
• UDI-Device Identifier: 00885556179819
• UDI-Public: 00885556179819
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/14/2021

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: 74027273
• Device Catalogue Number: 74027273
• Device Lot Number: 19JM00839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 03/07/2021
• Supplement Report FDA Received Date: 06/14/2021
• 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