MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COMP RPSFLEX FEM CEM R MED; LCS COMPLETE : KNEE FEMORAL

Model Number	1294-11-030
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Muscular Rigidity (1968); Pain (1994)
Date of Event	12/30/2020
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
Clinical notification received for revision of right total knee arthroplasty, to address aseptic loosening of the tibial tray and femur, pain, and stiffness.Date of implantation: (b)(6) 2011, date of revision: (b)(6) 2020, (right knee).Treatment: revision of tibial tray, femur, and tibial insert.

• Brand Name: LCS COMP RPSFLEX FEM CEM R MED
• Common Device Name: LCS COMPLETE : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11261262
• Report Number: 1818910-2021-02191
• Device Sequence Number: 11435032
• Product Code: NJL
• UDI-Device Identifier: 10603295022848
• UDI-Public: 10603295022848
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2021

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: 1294-11-030
• Device Catalogue Number: 129411030
• Device Lot Number: 3116672
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 02/18/2021
• 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: LCS COMP RPS INS MED 10MM; LCS COMP RPSFLEX FEM CEM R MED; LCS COMPLETE LO PRO POLPAT MED; MBT CEM KEEL TIB TRAY SZ2; SMARTSET MV 40G - EO; SMARTSET MV 40G - EO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 82