MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC.1818910 SELF CENT HIP 48X28 BRN HIP OTHER IMPLANT

Catalog Number 103548000

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Embolism (1829)

Event Date 08/20/2017

Event Type  Death  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event 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.

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: SELF CENT HIP 48X28 BRN
• Type of Device: HIP OTHER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6876468
• MDR Text Key: 86621962
• Report Number: 1818910-2017-24930
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K812672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 103548000
• Device Lot Number: C47996
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/19/2017 Patient Sequence Number: 1