MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CUPULE MOBILE A BAGUE; HIP COMPONENT

Model Number PPT170XX

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Allegedly, a device report on the bipolar cup was requested and received from the ripo registry in february 2024.The report was reviewed on 20 march 2024.There were 40 revisions of the bipolar cup noted in the report for the following reasons: dislocation (n=21), cotiloiditis (n=7), stem aseptic loosening (n=6), unknown (n=4), and septic loosening (n=2).No other adverse events were reported.Additional information 04/02/2024: data provided by ripo over the years confirms that 20 of this revisions surgeries were already reported to microport orthopedics, only 20 of the reported incidents are new (11 dislocations, 2 cotyloiditis, 2 stem aseptic loosening, 3 unknown and 2 septic loosening).This incident is capturing the unknowns.

Manufacturer Narrative

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

• Brand Name: CUPULE MOBILE A BAGUE
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 19149072
• MDR Text Key: 340673606
• Report Number: 3010536692-2024-00271
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PPT170XX
• Device Catalogue Number: PPT170XX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention