MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMA MOD TIB TRAY CEM SZ5; SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY

Catalog Number	866025
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
Subject id: (b)(6).Clinical adverse event received for polywear resulting in osteolysis of the right femur zone.Event is serious and is considered moderate.Event is definitely related to device and definitely not related to procedure.Doi: (b)(6) 2001; doe: (b)(6) 2018; (right knee).06/04/2018 clinical notification received for revision due to osteolysis, polywear, loosening of all components.Revision occurred on (b)(6) 2018.
Additional Manufacturer Narrative
Product complaint # = > pc-(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, a follow-up medwatch will be filed as appropriate.

• Brand Name: PFC SIGMA MOD TIB TRAY CEM SZ5
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7637141
• Report Number: 1818910-2018-63109
• Device Sequence Number: 14014364
• Product Code: JWH
• UDI-Device Identifier: 10603295216803
• UDI-Public: 10603295216803
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K884796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2018

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: 866025
• Device Lot Number: 277178
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/04/2018
• Supplement Date Received by Manufacturer: 07/05/2018
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 07/17/2018
• 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: 111