MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 3-4 RT11; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CMNTD,POLYMR/METAL/POLYMR

Catalog Number	74023233
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/14/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery was performed due to knee luxation.Surgeon implanted a new insert.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.Evidence of wear was observed on the superior and inferior surfaces of the journey articular insert.There were signs of damage on the posterior region of the post.The tibial baseplate was not returned; therefore no further analysis could be conducted.There were no materials or manufacturing deviations noted in this lab analysis.A review of complaint history revealed no additional complaints for the listed batch.A review of the manufacturing records did not reveal any material or manufacturing deviations that could have caused or contributed to the reported incident.No clinical supportive documents have been provided for inclusion in this investigation.The future impact to the patient beyond the procedure cannot be determined.No further clinical/medical assessment is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: JOURN ART INS BCS STD 3-4 RT11
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CMNTD,POLYMR/METAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7147288
• Report Number: 1020279-2017-01337
• Device Sequence Number: 16421172
• Product Code: JWH
• UDI-Device Identifier: 03596010555014
• UDI-Public: 03596010555014
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2018

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 Expiration Date: 03/17/2017
• Device Catalogue Number: 74023233
• Device Lot Number: 07CM13659
• Initial Date Received by Manufacturer: 12/19/2017
• Supplement Date Received by Manufacturer: 12/19/2017
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 04/12/2018
• 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
• Patient Age: 71 YR
• Patient Weight: 78