MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 MBT POR TIBIAL TRAY SZ4; MBT TIBIAL TRAY : KNEE TIBIAL TRAY

Catalog Number	129432140
Medical Device Problem Code	Failure To Adhere Or Bond (1031)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Date of Event	02/16/2018
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
The patient was revised to address subsidence and loosening of the tibia at the cement to implant interface, depuy cement was used.Doi: (b)(6) 2012; dor: (b)(6) 2018; left knee.No surgical delay.
Additional Manufacturer Narrative
(b)(4).Investigation summary: no device associated with this report was received for examination.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MBT POR TIBIAL TRAY SZ4
• Common Device Name: MBT TIBIAL TRAY : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7448363
• Report Number: 1818910-2018-57965
• Device Sequence Number: 1718383
• Product Code: NJL
• UDI-Device Identifier: 10603295025702
• UDI-Public: 10603295025702
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2018

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: 129432140
• Device Lot Number: 3473399
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/16/2018
• Supplement Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 04/20/2018
• Supplement Report FDA Received Date: 06/15/2018
• 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
• Patient Age: 53 YR
• Patient Weight: 171