MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 SIGMA CR150 CEM SZ 4N RT; TRIAL INSTRUMENT

Catalog Number	196030450
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/16/2017
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
Der states late onset of infection, revised to antibiotic spacer.It was also stated that loosening occurred at the bone to cement and cement to implant interface.Depuy cement was used.Doi: (b)(6) 2015 ; dor: (b)(6) 2017 ; right knee.
Additional Manufacturer Narrative
Additional 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.Device history lot = > null.Device history batch = > null.Device history review = > null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SIGMA CR150 CEM SZ 4N RT
• Common Device Name: TRIAL INSTRUMENT
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; loughbeg, ringaskiddy co.; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 7114047
• Report Number: 1818910-2017-51562
• Device Sequence Number: 13771176
• Product Code: JWH
• UDI-Device Identifier: 10603295074977
• UDI-Public: 10603295074977
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K082500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 11/16/2017

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 196030450
• Device Lot Number: 8367631
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2017
• Supplement Date Received by Manufacturer: 01/10/2018; 08/29/2018
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 01/10/2018; 09/06/2018
• 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 Age: 77 YR