Endo-Model Modular Knee Prosthesis System 15-3816/12Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04026575034758), received between Jul 7, 2023 and Mar 16, 2026 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 reports).

2 FDA recall records name this device's identifier, 2 still open.

20 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.

Recalls naming this device

1. May 22, 2024Class IIOpen, Classified

   Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique

   Z-2410-2024 · Root cause: Process design · Recall details · FDA record ↗

2. May 24, 2022Class IIOpen, Classified

   There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.

   Z-1378-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026Separation Failure

  REPORTED THAT IN A PROCEDURE, THE BLIND SCREW ON THE COMPONENT COULD NOT BE BACKED OUT. AN ADDITIONAL COMPONENT WAS OPENED AND THE TIBIAL COMPONENT FROM THAT IMPLANT WAS INSTEAD USED IN THE PROCEDURE. ONLY A DELAY OF APPROXIMATELY 5 MINUTES WAS REPORTED. NOTE: THE REPRESENTATIVE DID ENSURE THE SURGEON UNDERSTOOD THAT THE ALTERNATE CEMENTING TECHNIQUE SHOULD BE USED PER THE FIELD NOTICE ASSOCIATED WITH THE BLIND SCREW REMOVAL ISSUES, HOWEVER THE SURGEON DID NOT AGREE WITH THIS APPROACH AND PREFERRED TO OPEN A NEW IMPLANT. [CUSTOMER].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24604051 ↗
• InjuryDec 20, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  NOTIFIED BY REPRESENTATIVE (B)(6) THAT DR. (B)(6) WILL PERFORM A REVISION FOR A FEMUR THAT IT LOOSE. REVISION IS PLANNED FOR (B)(6) 2024. [(B)(6)].

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 20986803 ↗
• InjuryDec 13, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  NOTIFIED ON 11/27/2024, BY REPRESENTATIVE (B)(6) THAT DR. (B)(6) WILL PERFORM A REVISION FOR A FEMUR THAT IS LOOSE.

  Patient problems: Insufficient Information

  MAUDE report 20925204 ↗
• InjuryMay 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PATIENT HAS SEVERE NICKEL ALLERGY. SYSTEM WAS IMPLANTED DURING REVISION TKA ON (B)(6) 2020 AND METAL AUGMENTS WERE REVISED TO UHMWPE AUGMENTS ON (B)(6) 2021. PATIENT HAS KNEE PAIN WHICH APPEARS LOCALIZED TO THE FEMUR AND AUGMENTS AND POSSIBLY TO PATELLA FEMORAL JOINT. SURGEON PLANS REVISION PENDING REQUEST UNDER COMPASSIONATE USE FOR TINBN-COATED METAL AUGMENTS AND TAPER FIXATION SCREWS. SURGERY HAS NOT YET OCCURRED.A LETTER RECEIVED FROM DR. (B)(6) ON (B)(6) 2024, STATING THAT IN HIS OPINION, THE POLY AUGMENTS MAY HAVE CONTRIBUTED TO LOOSENING.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 19386580 ↗
• InjuryNov 3, 2023Unstable; Malposition of Device; Unstable; Malposition of Device

  (B)(6) WAS NOTIFIED THAT (B)(6) THAT A REVISION SURGERY OCCURRED ON (B)(6) 2023 WITH DR. (B)(6) BECAUSE THERE SEEMED TO BE TOO MUCH INTERNAL ROTATION OF THE FEMORAL COMPONENT. [CUSTOMER].

  Patient problems: Failure of Implant

  MAUDE report 18064119 ↗
• InjuryJul 7, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  PATIENT, WHO HAD LINK HINGE KNEE WITH CUSTOM-COATED POREX FEMORAL AND TIBIAL AUGMENTS UNDERWENT REVISION SURGERY FOR FEMORAL LOOSENING. [CUSTOMER].

  Patient problems: Bone Shedding Debris; Failure of Implant; Hypersensitivity/Allergic reaction

  MAUDE report 17280073 ↗

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-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-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-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-1539-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2220/40
• Z-1554-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2230/15
• 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-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-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-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-1541-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2220/52
• 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-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-1551-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number: 15-2230/12
• 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-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 5 more.