MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ACETABULAR CUP; HIP COMPONENT

Model Number PHA0-6258

Device Problem Malposition of Device (2616)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly the cup shifted into open position 3 months following initial super path thr.The patient mobilized and was driving after 6 weeks follow up.Asymptomatic and full weight bearing at first 6 weeks review.The patient had no pain initially up to mid (b)(6).But felt pain in week (b)(6) 2019.Reviewed (b)(6) x-rays, confirmed socket position change.Revised to size 50 group d procotyl® cup with ceramic bearing.Fluid and tissue samples taken by clinical team for routine for microscopy.

• Brand Name: ACETABULAR CUP
• 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: 8392205
• MDR Text Key: 137880609
• Report Number: 3010536692-2019-00483
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PHA0-6258
• Device Catalogue Number: PHA0-6258
• Device Lot Number: 1713828
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/13/2019
• Date Manufacturer Received: 02/13/2019
• 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