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

Medical Device Problem Codes	Loss of or Failure to Bond (1068); Fracture (1260)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The article discussed that the patients were weight bearing as tolerated.A review of the product labeling identified the following precaution" the remedy spectrum® gv hip 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 hip.Always use the largest component size possible to ensure ideal performance.It is essential that the patient use mobility-assisted devices (e.G., crutches, walker, cane) during the implantation period." the article did not discuss the implantation technique for implantation of the stem into the canal.The product labeling identifies the following warning "the remedy spectrum® gv hip spacer must be proximally cemented with gentamicin and vancomycin loaded cement.The use of bone cement is compulsory to avoid rotation and to limit the risk of dislocation or spacer loosening." the article demonstrated that additional cement can be beneficial in addition to the use of the monomer.The product labeling contains the following note: "the remaining offset space and threads of the stem, up to the femoral head, must be filled with gentamicin and vancomycin loaded bone cement.".
Event or Problem Description
Journal of orthopaedic experience and innovation vol.6, issue2, 2025 included reserach article "stability of osteoremedies remedy hip spacer for two-stage revisions of prosthetic joing infections: single center analysis" included two patients who required spacer replacment.Information from the article: in this series, the osteoremedies® second-generation pre-molded antibiotic hip spacer proved to be a convenient and effective option during two-stage revisions for managing pjis, though it demonstrated a small risk of implant fracture and dislocation.This spacer demonstrated only 1 fracture and 1 dislocation of the 16 patients who used both stem and head pieces.Of the 16 patients who used both femoral components, a spacer fracture occurred in one case (6.25%).This patient underwent a spacer exchange.Based on initial post-operative x-rays, the degree of threading of the femoral neck into the head was 6 threads, but at the time of fracture, it had reduced to only 2 threads.This patient did not receive additional bone cement, and their bmi was 34.75 kg/m².When comparing this patient who experienced a spacer fracture to another in our cohort with the same thread count of 6 who did not fracture, the key differences between the two patients were the use of supplemental bone cement and bmi of 22.7 kg/m².Of the 16 patients who used both femoral components, a spacer dislocation occurred in 1 case (6.25%).In this case, the spacer was exchanged with a different spacer.The degree of threading of the femoral neck into the head was 4 threads.For this patient, additional bone cement was not used, their bmi was 38.02 kg/m², and the patient reported a fall resulting in twisting of the affected limb.When comparing the demographics of the patient who experienced spacer dislocation to the other patient in our cohort with 4 threads who did not dislocate, the only differences were the use of supplemental cement, bmi 24.4 kg/m², and presence of trauma.Among the 16 patients who utilized both components, the femoral head was screwed onto the stem with an average of 7.75 (range: 4-9) threads.The average change in distance between the femoral head and stem components from post-spacer insertion to the most recent followup was 0.15 mm (range: -0.5 to 2.93 mm).Of the 10 patients who used supplemental bone cement around the junction between the femoral stem and head, the average change in distance was -0.15 mm.Of the 6 patients who did not use supplemental cement, the average change in distance was 0.78 mm.

• 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: 23824711
• Report Number: 3010537287-2025-00002
• Device Sequence Number: 5093233
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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?: Yes
• Operator of Device: Health Professional
• 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: 11/01/2025
• Initial Report FDA Received Date: 12/16/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown