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

Catalog Number	129432150
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Patient was implanted in (b)(6) 2007.(b)(6) 2013 pain and stiffness with audible squeaking.(b)(6) ¿ 1st stage revision as a precaution no evidence of infection.(b)(6) - 2nd stage revision.
Additional Manufacturer Narrative
Product complaint # :(b)(4).This product was reported in error.Depuy doesn¿t have the responsibility to make a reporting determination and submit adverse event reports for this instrument.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• Brand Name: MBT POR TIBIAL TRAY SZ5
• Common Device Name: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6962773
• Report Number: 1818910-2017-26871
• Device Sequence Number: 16429673
• Product Code: NJL
• UDI-Device Identifier: 10603295025719
• UDI-Public: 10603295025719
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2017

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: 129432150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/22/2017
• Supplement Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 10/19/2017
• Supplement Report FDA Received Date: 09/20/2018
• 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: Required Intervention