MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA STAB GVF INS 5 10MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	158125010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Swelling (2091); No Code Available (3191)
Date of Event	03/01/2019
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.(b)(4).
Event or Problem Description
Re-revision knee replacement (tc3): patient received revision of a pfc with tc3 approx.3 months ago 1st revision (b)(6) 2019.Patient experienced a lot of post-op pain and swelling.Surgeon suspected possible infection.No explicit signs of infection on entering the joint.There was a considerable amount of scar tissue.Scar tissue removed, swabs taken to test for infection, stabalised liner exchanged.
Additional Manufacturer Narrative
(b)(4) due to receipt of additional information states that "swabs showed no infection present".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
Swabs showed no infection present.
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, a follow-up medwatch will be filed as appropriate.

• Brand Name: SIGMA STAB GVF INS 5 10MM
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8440667
• Report Number: 1818910-2019-88049
• Device Sequence Number: 19577584
• Product Code: JWH
• UDI-Device Identifier: 10603295064589
• UDI-Public: 10603295064589
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K033272
• 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): 03/01/2019

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: 158125010
• Device Lot Number: D14062197
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/01/2019
• Supplement Date Received by Manufacturer: 04/05/2019; 04/12/2019
• Initial Report FDA Received Date: 03/21/2019
• Supplement Report FDA Received Date: 04/30/2019; 05/01/2019
• 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