MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT CEM TIBIAL TRAY SZ3; MBT TIBIAL TRAY : KNEE TIBIAL TRAY

Model Number	1294-31-130
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/03/2021
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
Patient was revised due to loosening of the tibial component at the cement to implant interface.Doi: (b)(6) 2020 dor: (b)(6) 2021 left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: MBT CEM TIBIAL TRAY SZ3
• 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: 12526503
• Report Number: 1818910-2021-21023
• Device Sequence Number: 20123818
• Product Code: NJL
• UDI-Device Identifier: 10603295025603
• UDI-Public: 10603295025603
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2021

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: 1294-31-130
• Device Catalogue Number: 129431130
• Device Lot Number: 9489368
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/03/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 10/03/2021
• 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: MBT CEM TIBIAL TRAY SZ3; SIG RP AOX STB INS SZ3 15; MBT CEM TIBIAL TRAY SZ3; SIG RP AOX STB INS SZ3 15
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR