MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COM 3 PEG M/B PAT REP LG+; LCS COMPLETE : KNEE PATELLA

Model Number	1294-09-870
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	05/27/2020
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
Patient was revised to address infection.Doi: unknown.Dor: (b)(6) 2020; right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary the device associated with this report was not 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.H10 additional narraive:.

• Brand Name: LCS COM 3 PEG M/B PAT REP LG+
• Common Device Name: LCS COMPLETE : KNEE PATELLA
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10130000
• Report Number: 1818910-2020-13335
• Device Sequence Number: 16673271
• Product Code: NJL
• UDI-Device Identifier: 10603295022817
• UDI-Public: 10603295022817
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2020

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: 1294-09-870
• Device Catalogue Number: 129409870
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 06/08/2020
• Supplement Report FDA Received Date: 07/13/2020
• 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 COM 3 PEG M/B PAT REP LG+; LCS COMP RP INSERT LG+ 10MM; LCS CR RIGHT FEMUR LG+; RP TIBIA SZ 5; LCS COM 3 PEG M/B PAT REP LG+; LCS COMP RP INSERT LG+ 10MM; LCS CR RIGHT FEMUR LG+; RP TIBIA SZ 5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR