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

Model Number GVHDLG

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/27/2022

Event Type  Injury  

Manufacturer Narrative

The size head and size cup provided to the surgeon were not compatible and the error was not identifed until post op.The surgeon explanted the head device and implanted the size head that is compatible to the implanted cup.

Event Description

While the patient was in post-anaesthesia care unit (pacu) it was identifed that the size head implanted was not compatible with the size acetabular cup implanted.The doctor brought the patient back to the or explanted the head and implanted a head that was compatible with the acetabular cup size.

• 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: 14756059
• MDR Text Key: 295042130
• Report Number: 3010537287-2022-00007
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 00855195006548
• UDI-Public: 00855195006548
• Combination Product (y/n): Y
• PMA/PMN Number: K192885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• 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: GVHDSM
• Device Lot Number: OR00991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: REMEDY SPECTRUM GV FEMORAL STEM SM GVSTSM; REMEDY SPECTRUM® GV FEMORAL HEAD - 40MM GVHDXS; REMEDY® ACETABULAR CUP 40MM ID/48MM OD RHACXS
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female