MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT POR TIBIAL TRAY SZ5; MBT TIBIAL TRAY : KNEE TIBIAL TRAY

Model Number	1294-32-150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The patient had pain following a cyst that formed on the lateral femoral condyle.This necessitated the removal of the prosthesis.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: MBT POR TIBIAL TRAY SZ5
• Common Device Name: MBT TIBIAL TRAY : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11738121
• Report Number: 1818910-2021-09046
• Device Sequence Number: 3832703
• Product Code: NJL
• UDI-Device Identifier: 10603295025719
• UDI-Public: 10603295025719
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/19/2021

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: 1294-32-150
• Device Catalogue Number: 129432150
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 04/29/2021; 07/06/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 05/17/2021; 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LCS COMP RP INSERT LG 10MM; LCS COMPLETE FEM POR L LG; LCS COMPLETE POLY PATELLA LG; LCS COMP RP INSERT LG 10MM; LCS COMPLETE FEM POR L LG; LCS COMPLETE POLY PATELLA LG
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR