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

Model Number	RSKTLG
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Limited Mobility Of The Implanted Joint (2671)
Date of Event	01/14/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: STEMMED TIBIAL COMPONENT LG
• Manufacturer (Section D): OSTEOREMEDIES, LLC; 6075 poplar ave; memphis, tn 38119
• MDR Report Key: 11340270
• Report Number: 3010537287-2021-00002
• Device Sequence Number: 17268828
• Product Code: JWH
• UDI-Device Identifier: 00855195006685
• UDI-Public: 00855195006685
• Combination Product (Y/N): Y
• PMA/510(K) Number: K183017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: RSKTLG
• Device Catalogue Number: RSKTLG
• Device Lot Number: OR01124
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 181