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	No Code Available (3191)
Date of Event	08/20/2020
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
Suspected aseptic loosening.Surgery verified loosening of tibial tray with debonding between metal and cement.Some orsteolysis on later femoral condyle, but femur component was not loose.Infections test where taken and sent to lab to verify any infection.Pat.Was revised to a attune fb revision knee.No adverse events during surgery.No adverse events during surgery.
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 code(s) 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.Corrective action was not indicated.

• 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: 10502148
• Report Number: 1818910-2020-19509
• Device Sequence Number: 19638832
• Product Code: NJL
• UDI-Device Identifier: 10603295025603
• UDI-Public: 10603295025603
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2020

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: 1294-31-130
• Device Catalogue Number: 129431130
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/20/2020
• Supplement Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 10/29/2020
• 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: COMPETITOR CEMENT (DS CEMENT); LCS COMP RP INSERT STD 10MM; LCS COMPLETE FEM CEM R STD; COMPETITOR CEMENT (DS CEMENT); LCS COMP RP INSERT STD 10MM; LCS COMPLETE FEM CEM R STD
• Outcome Attributed to Adverse Event: Required Intervention