MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 SIGMA PS CEM FEM SZ4 L; SIGMA KNEE PRIMARY : KNEE FEMORAL

Catalog Number	196040400
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	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.(b)(4).
Event or Problem Description
Pfc revision knee insitu - same infected.All implants removed, joint washed out and debrided extensively.Attune revision implants inserted.
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SIGMA PS CEM FEM SZ4 L
• Common Device Name: SIGMA KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds IN LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 8447633
• Report Number: 1818910-2019-88272
• Device Sequence Number: 13560430
• Product Code: JWH
• UDI-Device Identifier: 10603295075059
• UDI-Public: 10603295075059
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K073529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• 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): 03/05/2019

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 Catalogue Number: 196040400
• Device Lot Number: 8587715
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 03/26/2019; 04/16/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 04/10/2019; 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention