MAUDE Adverse Event Report: OSTEOREMEDIES, LLC REMEDY HIP SPACER

Model Number RHSTMD

Device Problem Detachment Of Device Component (1104)

Patient Problem Failure of Implant (1924)

Event Date 05/18/2017

Event Type  Injury  

Manufacturer Narrative

The results of the investigation were inconclusive based upon the information available and the evaluation of the explant image.The event appears may be due to the head and stem not properly fixed during implantation.It is unknown if the patient followed surgeon's instructions for partial weight-bearing.

Event Description

Seven days post-operative the patient was rising from a sitting position and heard a sound in their hip.The patient went to the doctor and it was identified that the femoral head had disassociated from the femoral stem.A revision surgery was performed and the spacer was replaced with a new spacer.

• Brand Name: REMEDY HIP SPACER
• Type of Device: HIP SPACER
• 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: 6747113
• MDR Text Key: 81180493
• Report Number: 3010537287-2017-00006
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 00855195006265
• UDI-Public: 00855195006265
• Combination Product (y/n): N
• PMA/PMN Number: K112470
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RHSTMD
• Device Catalogue Number: RHSTMD
• Device Lot Number: OR00444
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/30/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 91