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

Model Number	1294-29-050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Date of Event	10/11/2020
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
Revision of an lcs revision due to loosening, infection and fracture (loosening and fracture are unspecified).Dor: (b)(6) 2020.
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.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 lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: LCS COMPLETE REVFEM CEM L STD+
• Common Device Name: LCS REVISION : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10727004
• Report Number: 1818910-2020-23222
• Device Sequence Number: 14484138
• Product Code: NJL
• UDI-Device Identifier: 10603295025535
• UDI-Public: 10603295025535
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1294-29-050
• Device Catalogue Number: 129429050
• Device Lot Number: 399014
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/11/2020
• Supplement Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 01/05/2021
• 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 COM POST AUG 10MM STD+; LCS COMP VVC INS STD+ 15MM; LCS COMPLETE REVFEM CEM L STD+; MBT REVISION CEM TIB TRAY S2.5; MBT TRAY SLEEVE POR M/L 45MM; UNIVERSAL FEM SLV DIS POR 40MM; UNIVERSAL STEM 115X16MM FLUTED; UNIVERSAL STEM 75X22MM FLUTED; LCS COM POST AUG 10MM STD+; LCS COMP VVC INS STD+ 15MM; LCS COMPLETE REVFEM CEM L STD+; MBT REVISION CEM TIB TRAY S2.5; MBT TRAY SLEEVE POR M/L 45MM; UNIVERSAL FEM SLV DIS POR 40MM; UNIVERSAL STEM 115X16MM FLUTED; UNIVERSAL STEM 75X22MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention