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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. SLT TAPER COBALT-CHROME FEMORAL HEAD HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. SLT TAPER COBALT-CHROME FEMORAL HEAD HIP COMPONENT Back to Search Results
Model Number 2601-2601
Device Problems Disassembly; Detachment of Device or Device Component
Event Date 06/19/2018
Event Type  Injury  
Manufacturer Narrative

This complaint will be updated once investigation is complete. Trends will be evaluated.

 
Event Description

Allegedly, primary surgery was performed with superpath on (b)(6) 2018. After 2 weeks, the surgeon suspected a dissociation and found it. The surgeon performed revision surgery at (b)(6) 2018. The cup will be returned. ((b)(4)).

 
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Brand NameSLT TAPER COBALT-CHROME FEMORAL HEAD
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 Key7665171
Report Number3010536692-2018-00900
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/05/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/05/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Device MODEL Number2601-2601
Device Catalogue Number2601-2601
Device LOT Number1722704
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/26/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/29/2018
Event Location No Information
Date Manufacturer Received06/29/2018
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

Patient TREATMENT DATA
Date Received: 07/05/2018 Patient Sequence Number: 1
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