MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 3-4 RT 9; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74023231
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, after a tka surgery had been performed, the patient experienced pain.A revision surgery was performed to exchange the journ articular insert bcs std 3-4 rt 9.The patient outcome is unknown.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to pain.Patella and tibial insert were exchanged.The primary surgery was performed in 2009.The revision was done after about eleven years insitu in 2020.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.A medical analysis noted that two undated x-rays were provided for review and show a lateralization of the patella but no comparison is available if change over time.No root cause can be concluded based on the x-rays provided.The impact to the patient beyond the revision surgery and recovery cannot be determined.Based on the limited information available, the root cause of the pain cannot be concluded.This could be normal wear, however, the patient¿s activity level nor any trauma was reported that might precipitate the pain.No adequate materials (operative reports) to fully evaluate the complaint, thus no further investigation is warranted for this complaint.Smith and nephew 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 RT 9
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10624623
• Report Number: 1020279-2020-05119
• Device Sequence Number: 2630516
• Product Code: JWH
• UDI-Device Identifier: 03596010554994
• UDI-Public: 03596010554994
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/29/2018
• Device Model Number: 74023231
• Device Catalogue Number: 74023231
• Device Lot Number: 08KM24130
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 02/15/2021
• Initial Report FDA Received Date: 10/04/2020
• Supplement Report FDA Received Date: 02/16/2021
• 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