MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC.1818910 CEMENTRALIZER 12.0; HIP FEMORAL HEAD

Catalog Number	137621000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Death (1802); Embolism (1829)
Date of Event	08/20/2017
Type of Reportable Event	Death
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
It was reported that after implanting the revision products, the patient was closed up and began experiencing problems.The patient died in room.The surgeon later stated that it was probably due to fat embolism.Competitor cement was reported to be used during the revision.
Additional Manufacturer Narrative
No device associated with this report was received for examination.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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: CEMENTRALIZER 12.0
• Common Device Name: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6876365
• Report Number: 1818910-2017-24928
• Device Sequence Number: 19035023
• Product Code: LTO
• UDI-Device Identifier: 10603295034452
• UDI-Public: 10603295034452
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K871510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2017

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: 137621000
• Device Lot Number: 697774
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/20/2017
• Supplement Date Received by Manufacturer: 10/18/2017
• Initial Report FDA Received Date: 09/19/2017
• Supplement Report FDA Received Date: 10/18/2017
• 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: Death
• Patient Age: 81 YR