MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COMPLETE POLY PATELLA STD+; LCS COMPLETE : KNEE PATELLA

Model Number	1294-09-550
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyst(s) (1800); Inflammation (1932); Pain (1994); No Code Available (3191)
Date of Event	06/18/2020
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
A std+ patella was removed from the right knee by surgeon, and replaced with a new std+ patella.The patient presented with throbbing pain in the right knee, mostly around the tibial region.A bone scan showed an inflamed patella.Intraoperatively, surgeon removed the patella component, and found several cysts in the patella bone.The cysts were cleared out and a new patella implanted.Surgeon checked the femoral, poly and tibial components and apart from slight wear on the polyethylene insert, dr decided these a were ok to leave in situ.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.
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.

• Brand Name: LCS COMPLETE POLY PATELLA STD+
• Common Device Name: LCS COMPLETE : KNEE PATELLA
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10213045
• Report Number: 1818910-2020-14694
• Device Sequence Number: 14054566
• Product Code: NJL
• UDI-Device Identifier: 10603295022589
• UDI-Public: 10603295022589
• 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: 2012
• Device Explanted Year: 2020
• 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): 06/18/2020

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: 1294-09-550
• Device Catalogue Number: 129409550
• Device Lot Number: 3419997
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 07/02/2020; 07/22/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 07/07/2020; 07/27/2020
• 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 COMP RP INSERT STD+ 12.5MM; UNKNOWN KNEE FEMORAL; UNKNOWN KNEE FEMORAL; UNKNOWN KNEE TIBIAL INSERT; UNKNOWN KNEE TIBIAL TRAY; UNKNOWN KNEE TIBIAL TRAY; UNKNOWN KNEE FEMORAL; UNKNOWN KNEE TIBIAL INSERT; UNKNOWN KNEE TIBIAL TRAY
• Outcome Attributed to Adverse Event: Required Intervention