MAUDE Adverse Event Report: OSTEOREMEDIES, LLC REMEDY STEMMED KNEE; STEMMED TIBIAL COMPONENT LG

Model Number RSKTLG

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Limited Mobility Of The Implanted Joint (2671)

Event Date 01/14/2021

Event Type  Injury  

Manufacturer Narrative

Per the device labeling, the remedy® stemmed knee spacer may be compromised in an overweight or obese patient and/or one who does not limit the amount of activity and weight placed on the knee.The patient is obese and reported walking on the device with full weight bearing.

Event Description

One month post-operative the patient was walking full weight bearing and fractured the tibial knee component.The surgeon revised the knee to remove the broken spacer and replace it with a metal tibial and femur static spacer.

• Brand Name: REMEDY STEMMED KNEE
• Type of Device: STEMMED TIBIAL COMPONENT LG
• 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: 11340270
• MDR Text Key: 232334897
• Report Number: 3010537287-2021-00002
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00855195006685
• UDI-Public: 00855195006685
• Combination Product (y/n): Y
• PMA/PMN Number: K183017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RSKTLG
• Device Catalogue Number: RSKTLG
• Device Lot Number: OR01124
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2021
• 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: 58 YR
• Patient Weight: 181