MRS 6485-3-211Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327048391), received between Jan 6, 2022 and Jan 6, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (1 report).

14 other recalls cover devices cleared under the same FDA submission (K222056, K233261, K241716, K952970); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2022Fracture; Fracture

  ROKEN MRS 11MM INTERCALARY CEMENTED STEM.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 13182169 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K222056, K233261, K241716, K952970. One submission often covers many models, so check the product and lot details in each record.

• Z-2732-2024 · Aug 5, 2024 · Open, Classified
  Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
• Z-0926-2008 · Nov 15, 2007 · Terminated
  Stryker Modular Replacement System Curved Cemented Stem; MRS 15x127 Curved Femoral Stem. Catalog Number: 6485-3-715; Stryker Orthopaedics Mahwah, NJ 07430
• Z-0917-2008 · Nov 15, 2007 · Terminated
  Stryker Modular Replacement System Curved Cemented Stem; MRS SM Curved Femoral Stem 10x102; Catalog Number: 6485-3-300; Stryker Orthopaedics Mahwah, NJ 07430
• Z-0927-2008 · Nov 15, 2007 · Terminated
  Stryker Modular Replacement System Curved Cemented Stem; MRS 17x127 Curved Femoral Stem. Catalog Number: 6485-3-717; Stryker Orthopaedics Mahwah, NJ 07430
• Z-0925-2008 · Nov 15, 2007 · Terminated
  Stryker Modular Replacement System Curved Cemented Stem; MRS 13x127 Curved Femoral Stem. Catalog Number: 6485-3-713; Stryker Orthopaedics Mahwah, NJ 07430
• Z-0922-2008 · Nov 15, 2007 · Terminated
  Stryker Modular Replacement System Curved Cemented Stem; MRS 15mmx203mm Femoral Stem. Catalog Number: 6485-3-315; Stryker Orthopaedics Mahwah, NJ 07430
• Z-0923-2008 · Nov 15, 2007 · Terminated
  Stryker Modular Replacement System Curved Cemented Stem; MRS 17mmx203 Femoral Stem. Catalog Number 6485-3-317; Stryker Orthopaedics Mahwah, NJ 07430
• Z-0919-2008 · Nov 15, 2007 · Terminated
  Stryker Modular Replacement System Curved Cemented Stem; MRS Small Curved Femoral Stem 9 x 102. Catalog Number: 6485-3-309; Stryker Orthopaedics Mahwah, NJ 07430
• Z-0921-2008 · Nov 15, 2007 · Terminated
  Stryker Modular Replacement System Curved Cemented Stem; MRS 12mmx203 Femoral Stem. Catalog Number: 6485-3-313; Stryker Orthopaedics Mahwah, NJ 07430
• Z-0918-2008 · Nov 15, 2007 · Terminated
  Stryker Modular Replacement System Curved Cemented Stem; MRS Small Curved Femoral Stem 8x102. Catalog Number 6485-3-308; Stryker Orthopaedics Mahwah, NJ 07430
• Z-0924-2008 · Nov 15, 2007 · Terminated
  Stryker Modular Replacement System Curved Cemented Stem; MRS 11x127 Curved Femoral Stem. Catalog Number: 6485-3-711; Stryker Orthopaedics Mahwah, NJ 07430
• Z-0920-2008 · Nov 15, 2007 · Terminated
  Stryker Modular Replacement System Curved Cemented Stem; MRS 11mmx203mm femoral stem. Catalog Number: 6485-3-311; Stryker Orthopaedics Mahwah, NJ 07430
• Z-0587-03 · Jan 7, 2003 · Terminated
  Modular femoral and proximal tibial replacement system consisting of femoral head/neck, body, stem and condyle components. Also proximal tibial body rotating hinge-type knee and s
• Z-0588-03 · Jan 7, 2003 · Terminated
  Modular Replacement System with Extra-Cortical Porous Coating, Femoral Module Stem and Tibial Module Stem