MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 PFC SIG RPF INS SZ 3 15MM; PFC SIGMA RP-F : KNEE TIBIAL INSERT

Catalog Number	951032
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	12/07/2017
Type of Reportable Event	Serious Injury
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
Subject: (b)(6).Clinical adverse event received for instability.Event is not serious and is considered moderate.Event is definitely related to device and definitely not related to procedure.Revision of insert.Doi: (b)(6) 2005.Doe: (b)(6) 2017.Dor: (b)(6) 2018, (left knee).
Additional Manufacturer Narrative
Product complaint #: (b)(4).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 will be filed as appropriate.

• Brand Name: PFC SIG RPF INS SZ 3 15MM
• Common Device Name: PFC SIGMA RP-F : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 7442582
• Report Number: 1818910-2018-57738
• Device Sequence Number: 1030092
• Product Code: NJL
• UDI-Device Identifier: 10603295230397
• UDI-Public: 10603295230397
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2018

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: Health Professional
• Device Catalogue Number: 951032
• Device Lot Number: Z39HG4000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 11/21/2018
• 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
• Patient Weight: 91