MAUDE Adverse Event Report: OSTEOREMEDIES, LLC REMEDY HIP SPACER; HIP SPACER, PROSTHETIC, PRODUCT CODE KWL

Model Number RHHDMD

Device Problem Detachment Of Device Component (1104)

Patient Problem Failure of Implant (1924)

Event Date 12/06/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The femoral head dislocated from the stem.A revision surgery was performed to remove the original implants and implant a new femoral head and stem.

• Brand Name: REMEDY HIP SPACER
• Type of Device: HIP SPACER, PROSTHETIC, PRODUCT CODE KWL
• Manufacturer (Section D): OSTEOREMEDIES, LLC; 6075 poplar ave; memphis TN 38119
• Manufacturer (Section G): OSTEOREMEDIES, LLC; 6075 poplar ave; memphis TN 38119
• Manufacturer Contact: chris hughes ; 6075 poplar ave; memphis, TN 38119 ; 9017340445
• MDR Report Key: 6220105
• MDR Text Key: 63799260
• Report Number: 3010537287-2016-00008
• Device Sequence Number: 1
• Product Code: KWL
• 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: 12/21/2016

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?: Yes
• Device Operator: Health Professional
• Device Model Number: RHHDMD
• Device Catalogue Number: RHHDMD
• Device Lot Number: OR00378
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 01/03/2017
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 61 YR
• Patient Weight: 113