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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSTEOREMEDIES, LLC REMEDY SPECTRUM GV HIP SPACER; REMEDY GV HIP SYSTEM
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OSTEOREMEDIES, LLC REMEDY SPECTRUM GV HIP SPACER; REMEDY GV HIP SYSTEM Back to Search Results
Model Number GVHDLG
Medical Device Problem Code Break (1069)
Health Effect - Clinical Codes Failure of Implant (1924); Joint Dislocation (2374)
Date of Event 07/05/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Remedy spectrum gv hip spacer labeling states "it is essential that the patient use mobility-assisted devices (e.G., crutches, walker, cane) during the implantation period".It was reported that the patient was walking full weight bearing without the use of a mobility-assisted device.
 
Event or Problem Description
2 weeks post-op the head of the hip implant disassociated from the internal metal stem.The diassocated head and stem were explanted and replaced with a new head and stem.
 
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Brand Name
REMEDY SPECTRUM GV HIP SPACER
Common Device Name
REMEDY GV HIP SYSTEM
Manufacturer (Section D)
OSTEOREMEDIES, LLC
6075 poplar ave
memphis, tn 38119
MDR Report Key12246402
Report Number3010537287-2021-00006
Device Sequence Number16854218
Product Code KWL
UDI-Device Identifier00855195006548
UDI-Public00855195006548
Combination Product (Y/N)Y
PMA/510(K) Number
K172906
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/29/2021
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
Operator of Device Health Professional
Device Model NumberGVHDLG
Device Catalogue NumberGVHDLG
Device Lot NumberOR01240
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/06/2021
Initial Report FDA Received Date07/29/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 Yes
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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