MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ENDURON NEUT 48OD X 28ID; DURALOC IMPLANT : HIP POLY ACETABULAR LINERS

Catalog Number 124108025

Device Problem Naturally Worn (2988)

Patient Problems Osteolysis (2377); Not Applicable (3189)

Event Date 05/15/2015

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

Der states patients left hip was revised due to poly wear and osteolysis.A head and liner exchange was performed.Doi: (b)(6) 2001; dor: (b)(6) 2018; left hip.

Manufacturer Narrative

Product complaint #
=
> pc-(b)(4).Investigation summary
=
> no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ENDURON NEUT 48OD X 28ID
• Type of Device: DURALOC IMPLANT : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7586369
• MDR Text Key: 110593470
• Report Number: 1818910-2018-61737
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 124108025
• Device Lot Number: TN5BJ1018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2018
• Date Device Manufactured: 04/13/1999
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR