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

Model Number	GLBP2845
Medical Device Problem Codes	Difficult to Insert (1316); Fitting Problem (2183)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem 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.
Additional Manufacturer Narrative
Update device code.

• Brand Name: GLADIATOR BIPOLAR 45MM OD X 28MM ID
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9682724
• Report Number: 3010536692-2020-00104
• Device Sequence Number: 3414198
• Product Code: KWY
• UDI-Device Identifier: M684GLBP28451
• UDI-Public: M684GLBP28451
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K062693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2020

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 02/07/2020
• Supplement Report FDA Received Date: 09/17/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR