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 Codes	Break (1069); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/29/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed in the patient due to instability.Insert was found broken.No delay or additional injuries reported.A back up device was available.
Additional Manufacturer Narrative
The associated journey bcs articular insert was returned and evaluated.A lab analysis conducted during this investigation indicated that articulating surface of the insert was worn with discoloration.The insertion/extraction slot was damaged, likely due to removal.The tip of the post was broken off and damaged.There were no observations of material or manufacturing deviations in the course of this investigation.The batch number could not be identified on the part due to wear, thus the manufacturing records review cannot be performed at this time.Complaint history review could not be performed with any accuracy due to lack of batch information.Our clinical evaluation noted that no clinical documentation was provided.Without this information, the root cause of the reported event cannot be concluded.The reported instability and revision cannot be determined at this time.No further investigation 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.

• 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: 8351456
• Report Number: 1020279-2019-00697
• Device Sequence Number: 206399
• Product Code: JWH
• UDI-Device Identifier: 03596010555212
• UDI-Public: 03596010555212
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2019

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 Catalogue Number: 74023262
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 02/19/2019
• Supplement Report FDA Received Date: 05/23/2019
• 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