MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT CEM KEEL TIB TRAY SZ1.5; MBT TIBIAL TRAY : KNEE TIBIAL TRAY

Model Number	1294-33-115
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Naturally Worn (2988)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/23/2020
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 primary surgery was performed on (b)(6) 2008 via tka.In june 2020, the patient complained of a malfunction.On (b)(6) 2020, the revision surgery was performed by replacing the tibial tray (p/n: 129433115) and the tibial insert (p/n: 951015).The surgeon replaced natural patella with a patella component.During the surgery, the surgeon confirmed the wear of the tibial insert and the loosening of the tibial tray.The femoral component was not loosened.A little wear was seemed at the explanted tibial tray¿s surface, and the surgeon checked damage level of the implants, he judged that there was no complaint about the implants.The revision surgery was completed without any surgical delay.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.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.Corrective action was not indicated.H10 additional narrative: added: h6 (patient and device codes).H6 patient code: no code available (3191) used to capture the insufficient information.

• Brand Name: MBT CEM KEEL TIB TRAY SZ1.5
• 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: 10240405
• Report Number: 1818910-2020-15158
• Device Sequence Number: 2655544
• Product Code: NJL
• UDI-Device Identifier: 10603295025757
• UDI-Public: 10603295025757
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2020

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: 1294-33-115
• Device Catalogue Number: 129433115
• Device Lot Number: 2454961
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 07/24/2020
• 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: PFC SIG RPF INS SZ 1.5 10MM; UNKNOWN KNEE FEMORAL; PFC SIG RPF INS SZ 1.5 10 MM; UNKNOWN KNEE FEMORAL
• Outcome Attributed to Adverse Event: Required Intervention