MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. GLADIATOR BIPOLAR 45MM OD X 28MM ID; HIP COMPONENT

Model Number GLBP2845

Device Problems Difficult to Insert (1316); Fitting Problem (2183)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, shell did not attach to the ball.Additional information on 01/31/2020: reporter stated that during surgery the head did not attach to the shell.They were using a 28 head and a 45 bipolar shell.According to the reporter, he noticed that the plastic rim inside the shell did not seem flush to the shell (there was a 3-4mm gap) and he thinks that it may be the reason why the head did not attach to the shell.In the end, they used a 32 head and a 46 shell.These functioned well.

Manufacturer Narrative

Update device code.

• Brand Name: GLADIATOR BIPOLAR 45MM OD X 28MM ID
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9682724
• MDR Text Key: 178201024
• Report Number: 3010536692-2020-00104
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: M684GLBP28451
• UDI-Public: M684GLBP28451
• Combination Product (y/n): N
• PMA/PMN Number: K062693
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: GLBP2845
• Device Catalogue Number: GLBP2845
• Device Lot Number: 18079661818047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/17/2020
• Date Manufacturer Received: 01/17/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR