MAUDE Adverse Event Report: DEPUY IRELAND¿ 9616671 SIGMA STAB XLK INS 2.5 8MM; KNEE TIBIAL BEARING/INSERT

Catalog Number	158122108
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
Der states that there were no implant stickers inside the implant box.
Additional Manufacturer Narrative
No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Review of the device history records did not reveal any related manufacturing deviations or anomalies on the reported lot number.Depuy considers the investigation closed at this time.Should the 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 STAB XLK INS 2.5 8MM
• Common Device Name: KNEE TIBIAL BEARING/INSERT
• Manufacturer (Section D): DEPUY IRELAND¿ 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 6868635
• Report Number: 1818910-2017-24766
• Device Sequence Number: 13617953
• Product Code: JWH
• UDI-Device Identifier: 10603295064169
• UDI-Public: 10603295064169
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K040166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2017

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 Expiration Date: 04/30/2022
• Device Catalogue Number: 158122108
• Device Lot Number: 8527024
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/16/2017
• Supplement Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 09/15/2017
• Supplement Report FDA Received Date: 11/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1