MAUDE Adverse Event Report: DEPUY IRELAND 9616671 SIGMA STAB XLK INS 5 10MM; KNEE INSERT

Catalog Number	158125110
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/02/2017
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Patient was revised to address a draining sinus and was brought to or for i&d vs.Revision.It was confirmed that the tract went unto the joint.It was also reported that all components were removed and a one stage revision was performed.Frozen section was performed and infection was confirmed.
Additional Manufacturer Narrative
Product complaint # = > pc-(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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SIGMA STAB XLK INS 5 10MM
• Common Device Name: KNEE INSERT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork IN ; EI
• MDR Report Key: 7066871
• Report Number: 1818910-2017-50376
• Device Sequence Number: 13846688
• Product Code: JWH
• UDI-Device Identifier: 10603295064664
• UDI-Public: 10603295064664
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K040166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 158125110
• Device Lot Number: 8558654
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/02/2017
• Supplement Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 119