MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT TRAY SLEEVE POR M/L 29MM; MBT TIBIAL TRAY : KNEE TIBIAL TRAY ACCESSORY

Model Number	1294-54-000
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/01/2020
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
Aseptic loosening of the tibial component.Universal stem was fractured at the junction with the mbt revision tray patient status/ outcome / consequences, yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.) revision knee surgery, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, if yes, describe, revision knee surgery, is the patient part of a clinical study, unknown, (b)(4) device property of none, device in possession of none, (b)(4).Device property of none, device in possession of none, (b)(4).Device property of none, device in possession of none, (b)(4) device property of none, device in possession of none by checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.True.
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.Corrected: h6 patient code: no code available (3191) was used to capture insufficient information.

• Brand Name: MBT TRAY SLEEVE POR M/L 29MM
• Common Device Name: MBT TIBIAL TRAY : KNEE TIBIAL TRAY ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10215359
• Report Number: 1818910-2020-14764
• Device Sequence Number: 2641199
• Product Code: NJL
• UDI-Device Identifier: 10603295026402
• UDI-Public: 10603295026402
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2020

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: 1294-54-000
• Device Catalogue Number: 129454000
• Device Lot Number: FL2MY1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 08/03/2020
• 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: MBT REVISION CEM TIB TRAY S2.5; MBT STEP WEDGE SZ2.5 15MM; MBT TRAY SLEEVE POR M/L 29MM; PFC SIGMARP STB TB IN 2.5 10.0; UNIVERSAL STEM 75X16MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention