Endo-Model Modular Knee Prosthesis System 15-3950/06Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04026575431687), received between Sep 8, 2023 and Sep 8, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

22 other recalls cover devices cleared under the same FDA submission (K152431, K212742); 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 18, 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.

• InjurySep 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PATIENT HAD A LINK HINGE KNEE IMPLANTED (B)(6) 2022 AND SUBSEQUENTLY UNDERWENT REVISION KNEE SURGERY ON (B)(6) 2023 (REPORTED PREVIOUSLY IN COMPLAINT (B)(4)). THE PATIENT SUBSEQUENTLY EXPERIENCED PAIN. NO CAUSE WAS EVIDENT ON X-RAYS. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2023. PRESENCE OF REACTIVE TISSUE WAS NOTED. THE CAUSE IS UNKNOWN, BUT ACCORDING TO THE SALES REP, THE SURGEON SUSPECTED POTENTIAL INFECTION OR POTENTIAL ALLERGY TO CEMENT. WHEN THE DOCTOR FLEXED THE KNEE, THE FEMUR COMPONENT, WHICH HAD BEEN FIXED TO THE BONE VIA CEMENTING OF THE CONICAL STEM AND 50MM UHMWPE DISTAL FEMUR AUGMENT, CAME LOOSE FROM THE CEMENT. ALL KNEE COMPONENTS WERE THEN REPLACED DURING THE SURGERY. THE OPERATIVE REPORT FOR THE IMPLANTING SURGERY ON (B)(6) 2023 INDICATES THAT WHEN PREPARING TO IMPLANT THE FEMORAL COMPONENTS, THE CEMENT HAD BEEN MIXED ONE-TO-ONE WITH TOBRAMYCIN AND UPON REACHING DOUGHY CONSISTENCY WAS HAND PACKED AROUND THE FEMORAL COMPONENT (STEM), THE UHMWPE AUGMENT THEN PLACED, AND THE FEMORAL ASSEMBLY THEN INSERTED INTO THE CANAL.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 17709931 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152431, K212742. One submission often covers many models, so check the product and lot details in each record.

• Z-2410-2024 · May 22, 2024 · Open, Classified
  Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/03, 15-2814/04, 15-2815/11, 15-2815/12, 15-2816/11, 15-2816/12, 15-281
• Z-2411-2024 · May 22, 2024 · Open, Classified
  Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Component, Medium, W: 65mm 16-2817/07 Tibial Component, Large, W: 75m
• Z-1540-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2220/46
• Z-1545-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2230/04
• Z-1552-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2230/13
• Z-1539-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2220/40
• Z-1546-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2230/06
• Z-1547-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2230/07
• Z-1550-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2230/11
• Z-1542-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, LARGE Item Number: 15-2220/60
• Z-1544-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number: 15-2230/03
• Z-1543-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number: 15-2230/02
• Z-1549-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2230/10
• Z-1553-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2230/14
• Z-1548-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2230/08

…and 7 more.