MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. HYLAMER 10D 56 OR 68ODX28ID; HIP ACETABULAR INSERT/LINER

Catalog Number 125156025

Device Problems Disassembly (1168); Loss of Osseointegration (2408); Naturally Worn (2988)

Patient Problem Unspecified Infection (1930)

Event Date 01/08/2015

Event Type  Injury  

Event Description

Patient was revised due to suspected infection.The liner was noted to have rotated in vivo 180 degrees.The lip was oriented inferiorly.It is suggested that extensive poly wear compromised the locking mechanism over a period of time, allowing rotation of the liner.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: unavailable.

Manufacturer Narrative

Patient was revised due to suspected infection.The liner was noted to have rotated in vivo 180 degrees.The lip was oriented inferiorly.It is suggested that extensive poly wear compromised the locking mechanism over a period of time, allowing rotation of the liner.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.It would not be unreasonable to find poly material wear after the length of time reported as implanted.Infection after this length of time implanted is not likely to involve a device / device processing error.Based on the investigation the need for corrective action is not indicated.

• Brand Name: HYLAMER 10D 56 OR 68ODX28ID
• Type of Device: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4464322
• MDR Text Key: 21727200
• Report Number: 1818910-2015-12184
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK944538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 125156025
• Device Lot Number: SE8AH1032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/1998
• 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: 80 YR