MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 HYLAMER 10D 58 OR 70ODX28ID; DURALOC IMPLANT : HIP POLY ACETABULAR LINERS

Catalog Number 125158025

Device Problem Naturally Worn (2988)

Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)

Event Date 05/07/2018

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

Der stated that the patient had her hip replaced in (b)(6) 1996.She was experiencing some subluxation issues due to poly wear.The hip center had migrated superiorly over the years.A new liner and head were implanted as the other components were well fixed and in reasonable position.Doi: (b)(6) 1996; dor: (b)(6) 2018; right hip.

Manufacturer Narrative

Product complaint #:(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.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, a follow-up medwatch will be filed as appropriate. .

• Brand Name: HYLAMER 10D 58 OR 70ODX28ID
• 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: 7566070
• MDR Text Key: 109953572
• Report Number: 1818910-2018-61256
• Device Sequence Number: 1
• Product Code: HTY
• 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: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 125158025
• Device Lot Number: 514240047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2018
• Date Device Manufactured: 04/26/1996
• Is the Device Single Use?: No
• 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: 61 YR
• Patient Weight: 133