MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIGMA PLI GVF INS 4 15MM; KNEE TIBIAL BEARING/INSERT

Catalog Number	158104015
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/23/2017
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
It was reported that the implant doesn't seat within the tibial tray.
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.Product code (b)(4) work order /lot no.D15091878 was manufactured on (b)(4) 2015.23 parts were manufactured per specification and all raw materials met specification.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SIGMA PLI GVF INS 4 15MM
• Common Device Name: KNEE TIBIAL BEARING/INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; suzhou industrial park; warsaw IN 46581 0988
• MDR Report Key: 7042327
• Report Number: 1818910-2017-29327
• Device Sequence Number: 1423910
• Product Code: JWH
• UDI-Device Identifier: 10603295062639
• UDI-Public: 10603295062639
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K033272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2017

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 Catalogue Number: 158104015
• Device Lot Number: D15091878
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2017
• Supplement Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 11/17/2017
• Supplement Report FDA Received Date: 04/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1