MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 SIGMA STAB XLK INS 4 15MM; LINER

Catalog Number	158124115
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	11/17/2017
Type of Reportable Event	Malfunction
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
The patient was revised to address inflammation.It was also stated that the knee was not infected, the original liner was pulled out and a new liner was put but it would not lock.Another liner was used.Doi: unknown; dor:(b)(6) 2017; right knee.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Investigation summaryno device associated with this report was received for examination.Depuy synthes considers the investigation closed.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, a follow-up medwatch will be filed as appropriate. .

• Brand Name: SIGMA STAB XLK INS 4 15MM
• Common Device Name: LINER
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork IN ; EI
• MDR Report Key: 7113943
• Report Number: 1818910-2017-51559
• Device Sequence Number: 1131409
• Product Code: JWH
• UDI-Device Identifier: 10603295064510
• UDI-Public: 10603295064510
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K040166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/17/2017

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 158124115
• Device Lot Number: 7864794
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/17/2017
• Supplement Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR