MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 5-6 LT10; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74023262
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/21/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2019, while the patient was on rising from sitting position felt a clunk and the knee locked out but was able to unlock.On (b)(6) 2019 the knee locked out again and this time remained locked.On (b)(6) 2019 the patient went through a revision surgery for removal and replacement of the articular insert.
Additional Manufacturer Narrative
The associated journey bcs articular insert was returned and evaluated.A lab analysis conducted during this investigation indicated that returned insert and insert post fragment were examined visually and using optical microscopy.No destructive testing was conducted.The articulating surface of the insert is discolored and worn.There is damage on the posterior side.There were no observations of material or manufacturing deviations in the course of this investigation.No relevant supporting documentation was provided, therefore a thorough medical investigation 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 with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.No further investigation warranted for this complaint; however 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 5-6 LT10
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8504689
• Report Number: 1020279-2019-01504
• Device Sequence Number: 13821463
• Product Code: JWH
• UDI-Device Identifier: 03596010555212
• UDI-Public: 03596010555212
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2019

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: 01/14/2019
• Device Catalogue Number: 74023262
• Device Lot Number: 09AM12927
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 07/11/2019
• 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