MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 ENDURON NEUT 54OD X 28ID; DURALOC IMPLANT : HIP POLY ACETABULAR LINERS

Catalog Number 124114000

Device Problem Naturally Worn (2988)

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

Event Date 05/16/2018

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 primary surgery was performed on (b)(6) 2002.When the patient visited to the hospital for the periodical medical check, the surgeon found that the liner was worn off under x-ray (date was unknown).It was reported that the revision surgery was performed on (b)(6) 2018.After the revision surgery, the surgeon found the surgeon confirmed the osteolysis of the proximal femur considered to be due to liner wear.No further information was provided by the hospital.

Manufacturer Narrative

Pc-(b)(4).Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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: ENDURON NEUT 54OD X 28ID
• Type of Device: DURALOC IMPLANT : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7591048
• MDR Text Key: 110729794
• Report Number: 1818910-2018-61887
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K940743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 124114000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2018
• 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: 68 YR