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

Model Number	1294-02-040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/25/2021
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
Patient primary left implants on (b)(6) 2020.She had an i&d and replacement of poly on (b)(6) 2020 (b)(4).This patient is very sick with multiple comorbidities.She had an abscess on the left knee surgical site.There was noticeable aseptic loosening of the femoral and patella components.All implants were removed with no plan to reimplant.Surgeon performed an end-stage arthrodesis.Her right knee was performed years ago and seems to be unaffected.Doi: (b)(6) 2021, dor: (b)(6) 2021, left 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).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: LCS COMPLETE FEM CEM L 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: 12480938
• Report Number: 1818910-2021-20245
• Device Sequence Number: 17096844
• Product Code: NJL
• UDI-Device Identifier: 10603295021629
• UDI-Public: 10603295021629
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 08/25/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1294-02-040
• Device Catalogue Number: 129402040
• Device Lot Number: 9290319
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 09/16/2021
• Supplement Report FDA Received Date: 09/22/2021
• 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 RP AOX INS STD 12.5; LCS COMPLETE FEM CEM L STD; LCS COMPLETE POLY PATELLA STD; MBT CEM TIBIAL TRAY SZ3; UNKNOWN BONE CEMENT; LCS COMP RP AOX INS STD 12.5; LCS COMPLETE FEM CEM L STD; LCS COMPLETE POLY PATELLA STD; MBT CEM TIBIAL TRAY SZ3; UNKNOWN BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR