MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIGMA STAB GVF INS 3 10MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	158123010
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2018
Type of Reportable Event	Malfunction
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.Concomitant med products: unknown knee tibial tray component; unknown knee femur component; sigma stab gvf ins 3 10mm knee tibial insert component; unknown knee patella component; unknown bone cement.
Event or Problem Description
Our customer service team indicated during product invoicing that physician implanted product after expire date.No information from customer available.No consequences for the patient reported.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Investigation summary 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 STAB GVF INS 3 10MM
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7869562
• Report Number: 1818910-2018-69164
• Device Sequence Number: 13937756
• Product Code: JWH
• UDI-Device Identifier: 10603295064251
• UDI-Public: 10603295064251
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K033272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2018

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: 158123010
• Device Lot Number: D13071077
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1