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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PRIME A-CLASS LINER 0°LIP 36MM HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. PRIME A-CLASS LINER 0°LIP 36MM HIP COMPONENT Back to Search Results
Model Number P2LXSC36
Device Problems Difficult to Insert; Difficult to Remove
Event Date 02/28/2020
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

Allegedly, the liner locked diagonally for the first time on (b)(6) operation after converting from a6 tab to a12 tab. Tried to remove the polyliner with a drill and tap in the instrument set, but no poly came out. Update please disregard 6-tab liner at this moment. So that's why reason is that there is only the 12-tab liner included on the incident form.

 
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Brand NamePRIME A-CLASS LINER 0°LIP 36MM
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 Key9933324
Report Number3010536692-2020-00326
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 04/07/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/07/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Device MODEL NumberP2LXSC36
Device Catalogue NumberP2LXSC361816848
Device LOT Number1816848
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/16/2020
Event Location No Information
Date Manufacturer Received03/16/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/07/2020 Patient Sequence Number: 1
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