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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSTEOREMEDIES, LLC REMEDY HIP SPACER; HIP SPACER, PROSTHETIC, PRODUCT CODE KWL, PRODUCT CODE: KWL
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OSTEOREMEDIES, LLC REMEDY HIP SPACER; HIP SPACER, PROSTHETIC, PRODUCT CODE KWL, PRODUCT CODE: KWL Back to Search Results
Model Number RHHDMD
Device Problem Detachment Of Device Component (1104)
Patient Problem Failure of Implant (1924)
Event Date 02/14/2017
Event Type  Injury  
Manufacturer Narrative
The results of the investigation were inconclusive based on the information available and the evaluation of the x-ray.The event appears may be due to the head and stem not being properly fixed during implantation.It is unknown if the patient followed surgeon's instructions for partial weight-bearing.Device not returned to manufacturer.
 
Event Description
Post op x-ray taken 8 days after implantation demonstrates that the femoral head disassembled from the stem.A revision surgery was performed and the spacer was replaced with a new spacer.
 
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Brand Name
REMEDY HIP SPACER
Type of Device
HIP SPACER, PROSTHETIC, PRODUCT CODE KWL, PRODUCT CODE: KWL
Manufacturer (Section D)
OSTEOREMEDIES, LLC
6075 poplar ave
memphis TN 38119
Manufacturer Contact
chris hughes
6075 poplar ave
memphis, TN 38119
9017340445
MDR Report Key6396109
MDR Text Key69623603
Report Number3010537287-2017-00003
Device Sequence Number1
Product Code KWL
Combination Product (y/n)N
PMA/PMN Number
K112470
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
Report Date 03/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberRHHDMD
Device Catalogue NumberRHHDMD
Device Lot NumberOR00400
Was Device Available for Evaluation? No
Date Manufacturer Received02/14/2017
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? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age53 YR
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