MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ENDURON NEUT 58 OR 70ODX28ID; HIP ACETABULAR INSERT/LINER

Catalog Number 124118025

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Osteolysis (2377)

Event Date 10/24/2017

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

The patient was revised to address painful hip, poly wear on the liner and osteolysis around the acetabulum.

Manufacturer Narrative

The patient was revised to address painful hip, poly wear on the liner and osteolysis around the acetabulum.The reported event has been evaluated and will be monitored.Depuy considers the investigation closed at this time.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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy considers the investigation closed at this time.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.

Manufacturer Narrative

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

• Brand Name: ENDURON NEUT 58 OR 70ODX28ID
• Type of Device: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7044884
• MDR Text Key: 92487112
• Report Number: 1818910-2017-29374
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 124118025
• Device Lot Number: WDL-47
• Initial Date Manufacturer Received: 10/24/2017
• Initial Date FDA Received: 11/20/2017
• Supplement Dates Manufacturer Received: 12/14/2017; 09/28/2018; 10/22/2018
• Supplement Dates FDA Received: 12/15/2017; 10/05/2018; 10/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR