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

Model Number	1294-31-150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/18/2020
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
Revision of an lcs lrg, lrg inlay 10mm and tibia size 5, and femoral component.Patient received an wc size 5, 15x30 stem, tibia size 4, 13x30 mm and inlay 15mm.Please note that during removal the cone from the inlay was knocked off.The patient was revised for progressive instability.The femoral component, tibial tray, and insert were revised.
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 : 1) quantity manufactured: (b)(4).2) date of manufacture: 11/october/2017 3) any anomalies or deviations identified in dhr: one scrap associated with this lot.There is no correlation with the complaint failure mode.A236 (tool breakage).No reprocessing associated with this lot.No deviations found.4) expiry date: 30/september/2022 5) ifu reference: 090200769.

• Brand Name: MBT CEM 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: 10734822
• Report Number: 1818910-2020-23306
• Device Sequence Number: 3457341
• Product Code: NJL
• UDI-Device Identifier: 10603295025627
• UDI-Public: 10603295025627
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 09/18/2020

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 Expiration Date: 09/30/2022
• Device Model Number: 1294-31-150
• Device Catalogue Number: 129431150
• Device Lot Number: 8643952
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 10/26/2020
• Supplement Report FDA Received Date: 12/15/2020
• 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 R LG; LCS COMP RP INSERT LG 10MM; LCS COMPLETE FEM POR R LG
• Outcome Attributed to Adverse Event: Required Intervention