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	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/26/2021
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
The patient was revised to address loosening of the femoral and tibial components at the bone to cement and cement to implant interfaces.Unknown bone cement was used.Osteolysis was also noted.Doi: 2000, dor: (b)(6) 2021, right knee.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary : no device associated with this report was received for examination.No product images or patient x-rays were provided.Examination did not find sufficient evidence to confirm loosening of the tibial tray depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing 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 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: 12485953
• Report Number: 1818910-2021-20346
• Device Sequence Number: 3349780
• Product Code: NJL
• UDI-Device Identifier: 10603295025627
• UDI-Public: 10603295025627
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2000
• 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): 08/26/2021

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: 1294-31-150
• Device Catalogue Number: 129431150
• Device Lot Number: 2240717
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 09/16/2021
• Supplement Report FDA Received Date: 10/25/2021
• 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: LARGE 3 PEG PATELLA POLY; LCS COMP RP INSERT LG 17.5MM; LCS COMPLETE FEM CEM R LG; MBT CEM TIBIAL TRAY SZ5; UNK MANUFACTURER & PRODUCT INFO; LARGE 3 PEG PATELLA POLY; LCS COMP RP INSERT LG 17.5MM; LCS COMPLETE FEM CEM R LG; MBT CEM TIBIAL TRAY SZ5; UNK MANUFACTURER & PRODUCT INFO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR