MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PFC SIGMARP CV TB/IN S2 15.0; TIBIAL INSERT

Catalog Number	962013
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Limited Mobility Of The Implanted Joint (2671)
Date of Event	11/07/2017
Type of Reportable Event	Serious Injury
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
Patient was revised to address painful stiff knee.It was also reported that the excessive tissue was cleaned out and a new poly was inserted.Original implant date was unknown.
Additional Manufacturer Narrative
Investigation summary: 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, a follow-up medwatch will be filed as appropriate. .
Additional Manufacturer Narrative
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, a follow-up medwatch will be filed as appropriate.

• Brand Name: PFC SIGMARP CV TB/IN S2 15.0
• Common Device Name: TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7087733
• Report Number: 1818910-2017-50874
• Device Sequence Number: 1209981
• Product Code: NJL
• UDI-Device Identifier: 10603295240594
• UDI-Public: 10603295240594
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2017

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: 962013
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/07/2017
• Supplement Date Received by Manufacturer: 09/23/2018; 10/11/2018
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 09/05/2018; 10/11/2018
• 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: Required Intervention