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InterSpace Knee

TECRES SPA · Model SPK0222 · UDI-DI 28031497000606

MBB JWH Prescription

510(k) clearances

3,709

Adverse events (49 deaths)

Recalls

Facilities

Description

Temporary knee spacer with gentamicin. InterSpace Knee is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement. The device is sterile and single-use. InterSpace Knee is indicated for temporary use (maximum of 180 days) as a total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. InterSpace Knee is applied on the femoral condyles and on the tibial plate following removal of the existing implantand radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Knee is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.).

Recalls

Date	Firm	Reason
2022-10-21	Howmedica Osteonics Corp.	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)
2015-02-11	DePuy Orthopaedics, Inc.	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.
2013-11-04	Zimmer, Inc.	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.
2013-09-16	DePuy Orthopaedics, Inc.	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
2006-11-07	Stryker Howmedica Osteonics Corp.	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

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.