MAUDE Adverse Event Report: OSTEOREMEDIES, LLC REMEDY SPECTRUM GV HIP SPACER; REMEDY GV HIP SYSTEM

Model Number GVHDLG

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Joint Dislocation (2374)

Event Date 07/05/2021

Event Type  Injury  

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 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.

• Brand Name: REMEDY SPECTRUM GV HIP SPACER
• Type of Device: REMEDY GV HIP SYSTEM
• Manufacturer (Section D): OSTEOREMEDIES, LLC; 6075 poplar ave; memphis, tn 38119
• Manufacturer Contact: chris hughes ; 6075 poplar ave; memphis, TN 38119 ; 9017340445
• MDR Report Key: 12246402
• MDR Text Key: 264259555
• Report Number: 3010537287-2021-00006
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 00855195006548
• UDI-Public: 00855195006548
• Combination Product (y/n): Y
• PMA/PMN Number: K172906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GVHDLG
• Device Catalogue Number: GVHDLG
• Device Lot Number: OR01240
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2021
• 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 Number: 1
• Patient Outcome(s): Required Intervention