MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT POR KEEL TIB TRAY SZ3; MBT TIBIAL TRAY : KNEE TIBIAL TRAY

Model Number	1294-34-130
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 was revised to address instability.No surgical delay.Doi: (b)(6) 2019.Dor: (b)(6) 2020; left knee.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: MBT POR KEEL TIB TRAY SZ3
• 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: 10102698
• Report Number: 1818910-2020-12849
• Device Sequence Number: 19603589
• Product Code: NJL
• UDI-Device Identifier: 10603295025870
• UDI-Public: 10603295025870
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2020

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: 1294-34-130
• Device Catalogue Number: 129434130
• Device Lot Number: 8889664
• Initial Date Received by Manufacturer: 05/18/2020
• Supplement Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 05/29/2020
• Supplement Report FDA Received Date: 07/02/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SIG C/R POROCOAT FEM LT SZ 4N; SIG RP AOX CRV INS SZ4 15
• Outcome Attributed to Adverse Event: Required Intervention