MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA STAB XLK INS 3 8MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	158123108
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Disorder (2373)
Date of Event	09/07/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
On 29-jun-2018: information received from colleague the patient had her knee implanted 7 years ago.She has had trouble with it from the beginning.Patient is curious if her knee has been recalled.No revision has been reported.Doi: 2011; dor: unknown; (unknown knee).
Additional Manufacturer Narrative
Pc-(b)(4).No 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 will be filed as appropriate.

• Brand Name: SIGMA STAB XLK INS 3 8MM
• 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: 7789251
• Report Number: 1818910-2018-66911
• Device Sequence Number: 16441093
• Product Code: JWH
• UDI-Device Identifier: 10603295064329
• UDI-Public: 10603295064329
• 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: 2011
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2018

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: No Information
• Device Expiration Date: 11/08/2015
• Device Catalogue Number: 158123108
• Device Lot Number: 3225292
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 08/16/2018
• Supplement Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention