MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. LINEAGE(R) TRANSCEND(R) SUPERFINISHED FEMORAL HEAD; HIP COMPONENT

Catalog Number 2600-0018

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This complaint will be updated once investigation is complete.Trends will be evaluated.

Event Description

As reported: allegedly the reason for revision was due to pain because of acetabular cup migration.Dr.(b)(6) explanted the dynasty biofoam 48 mm cup and 2 x screws (one was broken) and implanted a multihole cup from global orthopaedics.He left the profemur l stem insitu which was well fixed and removed the 28 mm metal head and replaced it with a 36 mm biolox delta femoral head microport ((b)(4), lot #166376).Au vigilance decision: tga reportable.(b)(4).

• Brand Name: LINEAGE(R) TRANSCEND(R) SUPERFINISHED FEMORAL HEAD
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 6919393
• MDR Text Key: 88401475
• Report Number: 3010536692-2017-01296
• Device Sequence Number: 1
• Product Code: JDL
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K004043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 2600-0018
• Device Lot Number: 1542311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/28/2017
• Date Manufacturer Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention