MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA CRVD GVF INS 2.5 10MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	158112010
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2018
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
It was reported that the tibial insert would not fully seat into tray.Doe: (b)(6) 2018.
Additional Manufacturer Narrative
Product complaint # : (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 CRVD GVF INS 2.5 10MM
• 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: 8189234
• Report Number: 1818910-2018-78979
• Device Sequence Number: 2266285
• Product Code: JWH
• UDI-Device Identifier: 10603295063216
• UDI-Public: 10603295063216
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K033272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2018

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: 158112010
• Device Lot Number: D17020762
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/27/2018
• Supplement Date Received by Manufacturer: 01/04/2019
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 01/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 71 YR