MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PFC*SIGMA TC3 FEM LEFT SZ5; SIGMA REVISION IMPLANT : KNEE FEMORAL

Catalog Number	960084
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Pain (1994); Joint Disorder (2373); No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)
Date of Event	04/16/2018
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.Concomitant med products: unknown knee tibial tray component; pfc*sigma tc3 fem left sz5; unknown knee tibial insert component; unknown knee patella component; smartset mv 40g ¿ eo 3122040 x 2; universal stem 115x14mm fluted; sigma fem adapter 7 degree; sigma fem adapter neutral bolt; universal fem slv dis por 40mm.
Event or Problem Description
Subject id: (b)(4) dots.Clinical notification received for revision related to loosening of femoral component.Doi: (b)(6) 2009.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.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.

• Common Device Name: SIGMA REVISION IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7780430
• Report Number: 1818910-2018-66518
• Device Sequence Number: 11056620
• Product Code: JWH
• UDI-Device Identifier: 10603295232513
• UDI-Public: 10603295232513
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K952830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2018

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: 960084
• Device Lot Number: DN8D54
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 09/13/2018; 09/20/2018
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 09/18/2018; 09/24/2018
• 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: 125