Bone Cement, Antibiotic

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2022-11-15Open, ClassifiedUnder Investigation by firm

  Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number: 6193-1-010

  Simplex HV With Gentamicin CE, 10 PACKS (P/N 6193-1-010) were distributed to customers who had ordered Simplex HV With Gentamicin in US, 10 PACKS (P/N 6195-1-010)

• 2015-03-05TerminatedUnder Investigation by firm

  SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement containing antibiotic. It is used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures. The bone cement has no intrinsic adhesive properties but relies instead on close mechanical interlock between the irregular bone surface and the prosthesis.

  One lot of SMARTSET GHV Gentamicin Bone Cement is partially agglomerated . This may result in surgical delays while a replacement package of cement is retrieved and mixed.

• 2014-01-13TerminatedOther

  Palacos R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 g Methyl Acrylate Copolymer, 20 ml Methyl Methacrylate Monomer 0.5 g Gentamicin, Distributed by Zimmer Dover, OH 44522 The cement is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.

  The patient label associated with the product may be incorrect in that the lot number on the patient label may be different than the lot number on the outer carton label.

• 2013-10-23TerminatedNo Marketing Application

  SmartSet Endurance GMV, Gentamicin, REF 3105-040, Medium Viscosity Antibiotic Bone Cement, Sterile. SmartSet GMV Endurance Gentamicin, bone cements are self-curing, radiopaque, polymethyl methacrylate based cements, containing antibiotic, used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures where infection by gentamicin-sensitive organisms is a potential risk.

  The SmartSet GMV Endurance Gentamicin Bone Cement, product ref: number 3105-040 is intended for use in indications that have not been cleared by the US FDA. The intended use stated in the IFU for the SmartSet GMV Endurance Gentamicin Bone Cement is for the fixation of prostheses to living bone in arthroplasty procedures of joints in which infection by gentamicin-sensitive organisms is a potentia

• 2007-01-10TerminatedOther

  Simplex P with Tobramycin. Antibiotic PMMA Bone Cement.

  The expiration date on the external label is incorrect in that it does not identify the earliest expiration date of the subcomponents. The External label provides for an incorrect longer expiration date than the actual subcomponents will support.