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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSTEOREMEDIES, LLC REMEDY SPECTRUM GV HIP; HIP SPACER, PRODUCT CODE: KWL
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OSTEOREMEDIES, LLC REMEDY SPECTRUM GV HIP; HIP SPACER, PRODUCT CODE: KWL Back to Search Results
Catalog Number GVHDSM
Device Problems Break (1069); Material Integrity Problem (2978)
Patient Problems Failure of Implant (1924); Limited Mobility Of The Implanted Joint (2671)
Event Date 12/08/2020
Event Type  malfunction  
Manufacturer Narrative
The use of cement on the threads contributed to the difficulty affixing the head to the stem.The extra force used to thread the head caused the head implant to break.No patient harm was reported only a delay in surgery of greater than 60 minutes.
 
Event Description
When affixing the head to the stem prior to implantation, the surgeon chose to use bone cement on the threads.Due to the bone cement setting up the surgical technician had difficulty threading the head onto the stem.The surgeon also attempted to thread the head down and due to amount of force being applied the head implant broke.The surgery was delayed for over 60 minutes while another head implant was obtained.There was no reported adverse event reported for the patient due to the surgical delay.
 
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Brand Name
REMEDY SPECTRUM GV HIP
Type of Device
HIP SPACER, 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 Key11096300
MDR Text Key240097765
Report Number3010537287-2020-00009
Device Sequence Number1
Product Code KWL
Combination Product (y/n)Y
PMA/PMN Number
K172906
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial
Report Date 12/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberGVHDSM
Device Lot NumberOR01041
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age56 YR
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