MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT STEP WEDGE SZ2.5 15MM; MBT TIBIAL TRAY : KNEE TIBIAL TRAY ACCESSORY

Model Number	1294-56-127
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.H10 additional narrative: added: h6 (patient).Corrected: b1, b2, h6 (device).H6 patient code: no code available (3191) was used to capture insufficient information.

• Brand Name: MBT STEP WEDGE SZ2.5 15MM
• 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: 10215369
• Report Number: 1818910-2020-14765
• Device Sequence Number: 16804620
• Product Code: NJL
• UDI-Device Identifier: 10603295026709
• UDI-Public: 10603295026709
• 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: 1294-56-127
• Device Catalogue Number: 129456127
• Device Lot Number: Y22GP1000
• 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