MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 ENDURON NEUT 54OD X 28ID; HIP ACETABULAR INSERT/LINER

Catalog Number 124114025

Device Problem Naturally Worn (2988)

Patient Problem Discomfort (2330)

Event Date 09/27/2017

Event Type  Injury  

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

Patient was revised to address polywear.Patient was experiencing some discomfort.

Manufacturer Narrative

Depuy considers the investigation closed at this time.Should the 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.

Manufacturer Narrative

(b)(4).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.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.

Event Description

Complaint description: patient was revised to address polywear.Update sep 27, 2017 after review of the records for reportability, identified "discomfort" patient harm in additional information, which had not been added to complaint.Discomfort added to patient harms, and femoral head reported for discomfort.Additional follow-up initiated to address followup liner reporting for the additional patient harm.Complaint updated on: oct 26, 2017.

• Brand Name: ENDURON NEUT 54OD X 28ID
• Type of Device: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6978743
• MDR Text Key: 90278859
• Report Number: 1818910-2017-27471
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K944538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 124114025
• Device Lot Number: R56TN1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention