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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 (1168); Detachment of Device or Device Component (2907)
Patient Problem No Information (3190)
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)).
 
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.
 
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Brand Name
SLT TAPER COBALT-CHROME FEMORAL HEAD
Type of Device
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key7665171
MDR Text Key113270731
Report Number3010536692-2018-00900
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 07/05/2018
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
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
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/29/2018
Initial Date Manufacturer Received 06/29/2018
Initial Date FDA Received07/05/2018
Supplement Dates Manufacturer Received06/29/2018
Supplement Dates FDA Received02/06/2020
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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