MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COMP RP INSERT STD 12.5MM; LCS COMPLETE : KNEE TIBIAL INSERT

Model Number	1294-05-412
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	03/23/2021
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
Revision total knee replacement for instability in flexion.Also patella tilt.Bearing changed and patella revised.Previous patella component removed and patella bone resected another 5mm.Bearing changed to a thicker bearing to address instability and patella revised and resurfaced with a further resection of patella bone and a patella re-implanted.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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.A concomitant product was identified to be a competitor product used in conjunction with the previously reported adverse event.

• Brand Name: LCS COMP RP INSERT STD 12.5MM
• Common Device Name: LCS COMPLETE : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11640675
• Report Number: 1818910-2021-07507
• Device Sequence Number: 19580165
• Product Code: NJL
• UDI-Device Identifier: 10603295022022
• UDI-Public: 10603295022022
• 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 Implanted Year: 2018
• Device Explanted Year: 2021
• 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,Followup
• Report Date (Section B): 03/23/2021

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: 1294-05-412
• Device Catalogue Number: 129405412
• Device Lot Number: HR3449
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 04/12/2021; 06/18/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 04/26/2021; 06/18/2021
• 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: COMPETITOR BONE CEMENT; LCS COMP RP INSERT STD 12.5MM; LCS COMPLETE FEM POR L STD; LCS COMPLETE POLY PATELLA STD; MBT CEM TIBIAL TRAY SZ3; LCS COMP RP INSERT STD 12.5MM; LCS COMPLETE FEM POR L STD; LCS COMPLETE POLY PATELLA STD; MBT CEM TIBIAL TRAY SZ3
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR