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

Model Number	GVHDLG
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/27/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3010537287-2022-00007
• Device Sequence Number: 1334378
• Product Code: KWL
• UDI-Device Identifier: 00855195006548
• UDI-Public: 00855195006548
• Combination Product (Y/N): Y
• PMA/510(K) Number: K192885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/10/2022

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: GVHDLG
• Device Catalogue Number: GVHDSM
• Device Lot Number: OR00991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: REMEDY SPECTRUM GV FEMORAL STEM SM GVSTSM; REMEDY SPECTRUM® GV FEMORAL HEAD - 40MM GVHDXS; REMEDY® ACETABULAR CUP 40MM ID/48MM OD RHACXS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female