MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COMP RPS INS STD 15MM; LCS COMPLETE : KNEE TIBIAL INSERT

Model Number	1294-16-415
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); No Code Available (3191)
Date of Event	08/18/2020
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
It was reported that the patient fell and disrupted her extensor mechanism.Full revision was done to increase stability.Patella remains insitu - no known reference or lot numbers available.Components originally implanted sometime in 2012 in (b)(6).No surgical delay is noted.Doi: 2012.Dor: (b)(6) 2020.Right 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.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: LCS COMP RPS INS STD 15MM
• 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: 10483076
• Report Number: 1818910-2020-19275
• Device Sequence Number: 1246050
• Product Code: NJL
• UDI-Device Identifier: 10603295023197
• UDI-Public: 10603295023197
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 08/18/2020

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: 1294-16-415
• Device Catalogue Number: 129416415
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 10/04/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 10/06/2020
• 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: UNK KNEE FEMORAL LCS; UNK KNEE TIBIAL TRAY RP; UNKNOWN KNEE PATELLA; UNK KNEE FEMORAL LCS; UNK KNEE TIBIAL TRAY RP; UNKNOWN KNEE PATELLA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 84