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U.S. Department of Health and Human Services

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

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MICROPORT ORTHOPEDICS INC. GLADIATOR BIPOLAR 45MM OD X 28MM ID HIP COMPONENT Back to Search Results
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.
 
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Brand NameGLADIATOR BIPOLAR 45MM OD X 28MM ID
Type of DeviceHIP 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 Key9682724
MDR Text Key178201024
Report Number3010536692-2020-00104
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062693
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other Health Care Professional
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 Received02/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberGLBP2845
Device Catalogue NumberGLBP2845
Device Lot Number18079661818047
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/17/2020
Event Location No Information
Date Manufacturer Received01/17/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/07/2020 Patient Sequence Number: 1
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