Remedy Spectrum GV Spacer GVHDSMRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00855195006524), received between Jun 11, 2025 and Dec 16, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 16, 2025Loss of or Failure to Bond; Fracture; Loss of or Failure to Bond; Fracture

  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 DI

  Patient problems: Inadequate Osseointegration

  MAUDE report 23824711 ↗
• InjuryJun 11, 2025Loss of or Failure to Bond; Fracture; Loss of or Failure to Bond; Fracture

  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).

  Patient problems: Limb Fracture

  MAUDE report 22188000 ↗