MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA CRVD GVF INS 3 15MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1581-13-015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Date of Event	07/19/2020
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
Revision total knee replacement; (b)(6) 2020; dair procedure for infection.Washout bearing change.Evidence of prior periprosthetic fracture of femur.Presence of plate and screws around prosthesis distal femur.Appears previous revision involving bearing change and also plate and screws for what appears to be peri prosthetic fracture of distal femur.Patient date of birth, primary surgeon, hospital and previous surgery dates including other details are unknown.Patient has not consented to the sharing of any information including that contained on this document.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.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.

• Brand Name: SIGMA CRVD GVF INS 3 15MM
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10351119
• Report Number: 1818910-2020-17286
• Device Sequence Number: 11454871
• Product Code: JWH
• UDI-Device Identifier: 10603295063353
• UDI-Public: 10603295063353
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K033272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/19/2020

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: 1581-13-015
• Device Catalogue Number: 158113015
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2020
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 07/31/2020
• Supplement Report FDA Received Date: 08/31/2020
• 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: CRUCIATE KEEL PFC TIBIAL COMPONENT; LEFT CR PFC FEMORAL COMPONENT; PLATES; SCREWS; SIGMA CRVD GVF INS 3 15MM
• Outcome Attributed to Adverse Event: Required Intervention