MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ENDURON 10D 54OD X 28ID; HIP ACETABULAR LINER

Catalog Number 124154025

Device Problem Naturally Worn (2988)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 poly wear.

Manufacturer Narrative

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 # pc-(b)(4).Investigation summary no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ENDURON 10D 54OD X 28ID
• Type of Device: HIP ACETABULAR LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 5743725905
• MDR Report Key: 7044293
• MDR Text Key: 92473818
• Report Number: 1818910-2017-50084
• 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,Followup
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 124154025
• Device Lot Number: SA5EP1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2018
• Date Device Manufactured: 01/05/1998
• 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: 78 YR