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

Model Number GVHDLG

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 08/23/2021

Event Type  Injury  

Manufacturer Narrative

Patient was pivoting to move from the bed to the wheelchair when the fracture occured.During explantation the surgeon observed bone cement between the head of the device and the patient acetabulum which could have attributed to the fracture.This surgical risk is included in the instructions for use.

Event Description

10 days post op the device was removed due to a fractured acetabulum.The patient did not fall.

• Brand Name: REMEDY SPECTRUM GV HIP SPACER
• Type of Device: HIP JOINT FEMORAL
• Manufacturer (Section D): OSTEOREMEDIES, LLC; 6800 poplar ave; memphis, tn 38119
• Manufacturer Contact: chris hughes ; 6800 poplar ave; memphis, TN 38119 ; 9017340445
• MDR Report Key: 12452659
• MDR Text Key: 270989845
• Report Number: 3010537287-2021-00008
• 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: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• 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: OR01056
• 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
• Patient Age: 65 YR