MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX NEUT 36IDX56OD; HIP ACETABULAR LINERS

Catalog Number 122136056

Device Problem Disassembly (1168)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 03/23/2018

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 states that patient has spontaneously disassociated the liner.The acetabular cup was explanted, and a new cup was placed.All implants explanted on (b)(6) 2018 has been sent to the returns department with a clearly written note indicating the hospital name.The surgeon is requesting a response regarding the findings from the returned liner and cup.Doi: (b)(6) 2013; dor: (b)(6) 2018; right hip.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: examination of the returned devices and provided x-rays confirmed the reported event.A worldwide complaint database search found no other reported incidents against the provided product/lot combination since release for distribution.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.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.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: ALTRX NEUT 36IDX56OD
• Type of Device: HIP ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7442618
• MDR Text Key: 105890866
• Report Number: 1818910-2018-57749
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072963
• 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: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 122136056
• Device Lot Number: 427174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2013
• 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: 80 YR