MAUDE Adverse Event Report: DEPUY IRELAND¿ 9616671 SIGMA CRVD XLK INS 4 8MM; KNEE TIBIAL BEARING/INSERT

Catalog Number	158114108
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/16/2007
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.
Event or Problem Description
Clinical der states that patient had an infection.Event meets the definition of serious.Event is noted to be not related to device.
Additional Manufacturer Narrative
Clinical der states that patient had an infection.Event meets the definition of serious.Event is noted to be not related to device.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 CRVD XLK INS 4 8MM
• Common Device Name: KNEE TIBIAL BEARING/INSERT
• Manufacturer (Section D): DEPUY IRELAND¿ 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 6727460
• Report Number: 1818910-2017-21350
• Device Sequence Number: 19065481
• Product Code: JWH
• UDI-Device Identifier: 10603295063506
• UDI-Public: 10603295063506
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K040166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2017

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: 158114108
• Device Lot Number: 2140526
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/20/2017
• Supplement Date Received by Manufacturer: 10/07/2017
• Initial Report FDA Received Date: 07/20/2017
• Supplement Report FDA Received Date: 10/09/2017
• 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: Other
• Patient Age: 71 YR
• Patient Weight: 70