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	Malposition of Device (2616)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/27/2020
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
Revision of a primary mbt tibial tray, insert and adding of a patella.Mbt tray revised to a mbt revision tray with stem, a new insert and we added a patella.Original case was done on the (b)(6) 2019 side being right.Surgeon stated the reason for this revision was malposition of the tray.
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.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• 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: 10810141
• Report Number: 1818910-2020-24214
• Device Sequence Number: 11797805
• Product Code: NJL
• UDI-Device Identifier: 10603295025719
• UDI-Public: 10603295025719
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• 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
• Report Date (Section B): 10/27/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1294-32-150
• Device Catalogue Number: 129432150
• Device Lot Number: 8949229
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 01/07/2021
• 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 STD+ 10MM; LCS COMP RP INSERT STD+ 10MM
• Outcome Attributed to Adverse Event: Required Intervention