MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS CNSTRD ART ISRT 3-4 RT 10M; PRSTHESIS,KNEE,PATELLOFMORTIBIL,SMICONSTRAIND,CMNTD, POLYMER/METAL/POLYMER

Model Number	74029232
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	07/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to a broken post.Only the inset was removed and a tall post insert was implanted.The patient outcome was unknown.
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 post of the device has broken off completely, rendering the device inoperative.The post was returned with the device.The device shows signs of extensive use.The lab analysis concluded that the as received component was visually inspected for signs of damage.The tibial insert showed signs of wear related damage to the articulating surface.Damage was observed to the medial inferior side of the implant.The post was fractured near the middle of the post.Signs of deformation were observed on the anterior, posterior, medial, and lateral regions of the insert post.No material or manufacturing defects were observed during this investigation.The clinical/medical evaluation concluded that this complaint from the united states reports a broken insert post on a journey knee.Smith and nephew has not received adequate materials (operative reports) to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.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.Some potential probable causes for this event could include but are not limited to a traumatic injury, surgical technique or overuse.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 CNSTRD ART ISRT 3-4 RT 10M
• Common Device Name: PRSTHESIS,KNEE,PATELLOFMORTIBIL,SMICONSTRAIND,CMNTD, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10382699
• Report Number: 1020279-2020-03804
• Device Sequence Number: 3551940
• Product Code: JWH
• UDI-Device Identifier: 00885556174463
• UDI-Public: 00885556174463
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K140555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2021

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: 74029232
• Device Catalogue Number: 74029232
• Device Lot Number: 06CMO8533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 08/19/2021
• 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