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

Catalog Number	GVHDSM
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Fracture (1260)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	05/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The femoral fracture seen on the post-op x-ray contributed to the disassociation of the spacer head from the stem.It was also reported that the patient could not be trusted to follow physician orders so it is possible that the patient was not using mobility assist device as required by the labeling.
Event or Problem Description
The patient had a hip spacer implanted on (b)(6) 2025 as part of a two-stage surgery to address the patient's primary joint infection.Post operative images taken on (b)(6) 2025 show a bone fracture in the femur that is assumed to have taken place intra-operatively during explantation of the previous device and the spacer implantation.Post operatively the femoral fracture propagated once patient weight was applied and the spacer head disassociated from the spacer stem.On (b)(6) 2025, the patient was taken back to surgery and revised with a girdlestone as the patient was still infected (culture positive).

• Brand Name: REMEDY SPECTRUM GV HIP SPACER
• Common Device Name: HIP JOINT FEMORAL
• Manufacturer (Section D): OSTEOREMEDIES LLC; 6800 poplar ave; suite 120; memphis TN 38119
• Manufacturer Contact: chris hughes ; 6800 poplar ave; memphis, TN 38119 ; 9017340445
• MDR Report Key: 22188000
• Report Number: 3010537287-2025-00001
• Device Sequence Number: 12888118
• Product Code: KWL
• UDI-Device Identifier: 00855195006524
• UDI-Public: 00855195006524
• Combination Product (Y/N): Y
• PMA/510(K) Number: K192885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2025

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 Catalogue Number: GVHDSM
• Device Lot Number: OR01970
• 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: 05/07/2025
• Initial Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 GV HIP STEM GVLSSM OR01787 00855195006586.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male