MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT REV TIB TRAY SIZE 4 15MM; MBT TIBIAL TRAY : KNEE TIBIAL TRAY

Model Number	1294-35-415
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	08/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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 loosening of the tibial component at the bone to implant interface.It was also reported that the patient had a revision knee done previously with tc3 and mbt revision implants.Records on the previous surgery were unavailable.Tibial component appears loose and the tibial stem has migrated through the lateral cortex distally.Plan is to remove the tibial component and replace it with a new tray with a longer stem.Doi: unknown, dor: (b)(6) 2020, right knee.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.

• Brand Name: MBT REV TIB TRAY SIZE 4 15MM
• 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: 10455141
• Report Number: 1818910-2020-18820
• Device Sequence Number: 11755861
• Product Code: NJL
• UDI-Device Identifier: 10603295026044
• UDI-Public: 10603295026044
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/12/2020

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: 1294-35-415
• Device Catalogue Number: 129435415
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 09/23/2020
• 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: TC3 RP TIBIAL INSERT S4,17.5; UNIVERSAL STEM 75X18MM FLUTED; TC3 RP TIBIAL INSERT S4,17.5; UNIVERSAL STEM 75X18 MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention