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	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	03/28/2020
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 has not been happy with knee since it was implanted and complaining of pain.Surgeon had scans of the knee done, and some hot spots showed up around the knee.Surgeon thought maybe the implant was loose.When removing the implant, the surgeon stated the implant was not loose but still removed due to patients request.
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 additional related 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.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch 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: 9954220
• Report Number: 1818910-2020-10656
• Device Sequence Number: 11454257
• 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: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2020

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: 8819690
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/28/2020
• Supplement Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 05/01/2020
• 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: DEPUY CMW 2G 40G; LCS COMP RP INSERT STD+ 12.5MM; LCS COMPLETE FEM POR L STD+; LCS COMPLETE POLY PATELLA STD+; MBT POR TIBIAL TRAY SZ3
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR