MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 SIGMA CRVD XLK INS 3 20MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1581-13-115
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); No Code Available (3191)
Date of Event	06/08/2020
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
Clinical notification received for revision of left total knee to address instability date of implantation: (b)(6) 2011.Date of revision: (b)(6) 2020 (left knee).Treatment: tibial insert revised.
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.
Event or Problem Description
On (b)(6) 2020, the patient underwent a bilateral knee revision with tibial insert exchanges due to instability, pain, and swelling.The right knee involved revision and implantation a depuy product, while the left knee involved revision and implantation of a competitor implant.Regarding the right knee, the surgeon indicated well-fixed components, no sign of infection, and no wear on the revised tibial insert.
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: b5 and h6 (patient codes).Corrected: b3, d1, d2, d3, d4 (catalog, lot # and udi), d7 and h4.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: SIGMA CRVD XLK INS 3 20MM
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork IN ; EI
• MDR Report Key: 10309705
• Report Number: 1818910-2020-16571
• Device Sequence Number: 16986805
• Product Code: JWH
• UDI-Device Identifier: 10603295063414
• UDI-Public: 10603295063414
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K040166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/08/2020

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: 1581-13-115
• Device Catalogue Number: 158113120
• Device Lot Number: 8145925
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 07/08/2020; 08/21/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 07/23/2020; 08/24/2020
• 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: COMPETITOR BONE CEMENT; COMPETITOR BONE CEMENT; PFC*SIGMA C/R NPOR FEM LT SZ 3; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG MOD TIB TRAY CEM COCR 3; SIGMA CRVD XLK INS 3 15MM; COMPETITOR BONE CEMENT; COMPETITOR BONE CEMENT; PFC*SIGMA C/R NPOR FEM LT SZ 3; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG MOD TIB TRAY CEM COCR 3; SIGMA CRVD XLK INS 3 15MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Weight: 118