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

Model Number	1294-01-040
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Edema (1820); Foreign Body Reaction (1868); Pain (1994); No Code Available (3191)
Date of Event	08/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(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
Patient received a right primary lcs to treat pain secondary to end-stage degenerative joint disease.The patella was resurfaced and depuy cement x 2 was utilized.The procedure was completed without complications.The surgeon notes there was severe patellar and tibial degeneration.The pcl, acl, and it band required release to treat the patient¿s natural tibial valgus.The procedure was completed without complications.Patient received a right tka revision to treat pain and swelling secondary to femoral component loosening.Upon entering the joint, the surgeon identified and evacuated blood-tinged fluid and synovial tissue consistent with foreign body reaction.The femoral component was loosened at an unknown interface.There was noted foreign body reactive fluid at the distal femoral flange.The patella and tibial tray were well-fixed and retained.There was minimal wear noted on the revised tibial insert.The patient was revised with depuy components utilizing competitor cement.The procedure was completed without complications.Doi: (b)(6) 2013.Doi: (b)(6) 2019; right knee.
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 related reported incidents against the provided product code/lot number combination since release for distribution.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.

• Brand Name: LCS COMPLETE FEM CEM R STD
• Common Device Name: LCS COMPLETE : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10362370
• Report Number: 1818910-2020-17456
• Device Sequence Number: 951176
• Product Code: NJL
• UDI-Device Identifier: 10603295021551
• UDI-Public: 10603295021551
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2020

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 Expiration Date: 01/31/2022
• Device Model Number: 1294-01-040
• Device Catalogue Number: 129401040
• Device Lot Number: 3410468
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/22/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 08/04/2020
• Supplement Report FDA Received Date: 09/03/2020
• 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: LCS COMP RP INSERT STD 10MM; LCS COMPLETE M/B PAT CEM STD; MBT CEM KEEL TIB TRAY SZ2.5; SMARTSET MV 40G - EO; SMARTSET MV 40G - EO; LCS COMP RP INSERT STD 10MM; LCS COMPLETE M/B PAT CEM STD; MBT CEM KEEL TIB TRAY SZ2.5; SMARTSET MV 40G - EO; SMARTSET MV 40G - EO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR