MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COMP RP INSERT LG+ 10MM; LCS COMPLETE : KNEE TIBIAL INSERT

Model Number	1294-05-710
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Health effect - clinical code: appropriate term / code not available (b)(4) used to capture the infection (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 underwent primary left tkr on (b)(6) 2016 where an uncemented lcs femoral component and an uncemented lcs tibial component were utilized patient has reported that the knee has never felt right and has had ongoing low levels of discomfort.Patient has presented to the gold coast university hospital following a bump to the knee with subsequent pain and swelling.The knee appeared to be infected.A washout was performed (date and surgeon unknown) and samples taken.Staph was grown/ cultivated.Doi: (b)(6) 2016 doe: unknown left knee.
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.H10 additional narrative:  added: e3.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: e1, e2.
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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: LCS COMP RP INSERT LG+ 10MM
• 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: 12067733
• Report Number: 1818910-2021-13588
• Device Sequence Number: 17171592
• Product Code: NJL
• UDI-Device Identifier: 10603295022220
• UDI-Public: 10603295022220
• 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: 2016
• 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): 06/08/2021

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: 1294-05-710
• Device Catalogue Number: 129405710
• Device Lot Number: C47755
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 07/04/2021; 08/30/2021
• Initial Report FDA Received Date: 06/25/2021
• Supplement Report FDA Received Date: 07/15/2021; 08/30/2021
• 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: DEPUY DUOFIX MBT TRAY SZ 5; LCS COMP RP INSERT LG+ 10MM; LCS COMPLETE FEM POR L LG+; DEPUY DUOFIX MBT TRAY SZ 5; LCS COMP RP INSERT LG+ 10MM; LCS COMPLETE FEM POR L LG+
• Outcome Attributed to Adverse Event: Required Intervention