MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT CEM TIBIAL TRAY SZ6; MBT TIBIAL TRAY : KNEE TIBIAL TRAY

Model Number	1294-31-160
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/09/2021
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
The patient was revised to address pain, bone loss and loosening of the femoral and tibial component at the cement to implant interface.A competitor cement was used.It was reported that the femur came off fiarly easy, the cement had debonded from the femur.There was a significant amount of bone loss.It was also reported that the oval dome patella was replaced due to wear.The tray was removed and the stem was well fixed.The implant was a sigma rp/ps flex knee.No surgical delay.Doi: 10-15 years ago, 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.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 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 SZ6
• 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: 11365881
• Report Number: 1818910-2021-03608
• Device Sequence Number: 1151335
• Product Code: NJL
• UDI-Device Identifier: 10603295025634
• UDI-Public: 10603295025634
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: LOSS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/09/2021

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: 1294-31-160
• Device Catalogue Number: 129431160
• Device Lot Number: 2167782
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 04/05/2021
• 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 SZ6; OVAL DOME PATELLA, SIGMA; PFC SIG RPF INS SZ6 15MM; SIZE 6 SIGMA RIGHT FLEX FEMUR; MBT CEM TIBIAL TRAY SZ6; OVAL DOME PATELLA, SIGMA; PFC SIG RPF INS SZ6 15MM; SIZE 6 SIGMA RIGHT FLEX FEMUR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR