Endo-Model Modular Knee Prosthesis System 15-3817/12Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04026575164059), received between May 22, 2024 and Jul 9, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 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 16, 2026.

Recalls naming this device

1. May 22, 2024Open, 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, 2022Open, 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE PATIENT HAD 2ND LEFT KNEE REVISION ON (B)(6) 2024, DURING WHICH A LINK HINGE KNEE WAS IMPLANTED. THE PATIENT EXPERIENCED PERSISTENT SWELLING AND EVENTUALLY ALSO INCREASED PAIN AND DECREASED ROM. AN INFECTION WORKUP WAS POSITIVE FOR STAPHYLOCOCCUS EPIDERMIS. REVISION SURGERY OCCURRED (B)(6) 2024 AND AN ANTIBIOTIC SPACER WAS PLACED. ACCORDING TO THE SURGEON, THE INFECTION WAS NOT DEVICE RELATED: THE PATIENT HAD A HISTORY OF MULTIPLE SURGERIES IN THE PAST AND VERY LIKELY HAD A HIDDEN INFECTION WITH STAPH EPIDERMIS THAT LED ULTIMATELY TO THE PROSTHETIC JOINT INFECTION, CAUSING FAILURE OF THE LINK IMPLANT.

  Patient problems: Implant Pain; Medical device site infection

  MAUDE report 22458174 ↗
• InjuryAug 30, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  NOTIFIED BY (B)(6) 2024 THAT A PATIENT BECAME INFECTED AND THE IMPLANTS HAD TO BE REMOVED AND WERE REPLACED BY A FUSION NAIL DEVICE. ORIGINALLY IMPLANTED ON (B)(6) 2022. FUSION NAIL PROCEDURE COMPLETED ON (B)(6) 2023. [CUSTOMER]

  Patient problems: Failure of Implant; Insufficient Information; Unspecified Infection

  MAUDE report 20105249 ↗
• InjuryAug 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  NOTIFIED BY DR. M ON AUG. 6, 2024 THAT A PATIENT BECAME INFECTED AND THE IMPLANTS HAD TO BE REMOVED AND WERE REPLACED BY A FUSION NAIL DEVICE. ORIGINALLY IMPLANTED ON (B)(6) 2022. FUSION NAIL PROCEDURE COMPLETED ON (B)(6) 2023.

  Patient problems: Medical device site infection

  MAUDE report 20070484 ↗
• InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS DEVICE WAS IMPLANTED (B)(6) 2021. PATIENT IS A 79-YEAR-OLD MAN WITH NICKEL ALLERGY AND HISTORY OR WORSENING PAIN IN HIS LEFT KNEE. PATIENT IS SCHEDULED FOR REVISION DUE TO APPARENT INFECTION.

  Patient problems: Hypersensitivity/Allergic reaction; Unspecified Infection

  MAUDE report 19815726 ↗
• InjuryMay 22, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  SYSTEM WAS IMPLANTED DURING REVISION TKA ON (B)(6) 2022. DR. REPORTS THAT OSTEOPOROTIC PATIENT WITH NICKEL ALLERGY IS EXPERIENCING PAIN ON WEIGHT BEARING AND THAT IMAGING INDICATES TIBIAL AND FEMORAL LOOSENING. SURGEON PLANS REVISION PENDING REQUEST UNDER COMPASSIONATE USE FOR REVISION COMPONENTS WITH POREX AND ZIRCONIA COATINGS. UPDATED 05-13-2024: IN A LETTER FROM DR. (B)(6) DATED MAY 9,2024, HE STATES THAT IN HIS OPINION, THE POLY AUGMENTS MAY HAVE CONTRIBUTED TO LOOSENING.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 19374958 ↗

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-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-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-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-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-1541-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2220/52
• 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-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-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-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-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-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-1542-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, LARGE Item Number: 15-2220/60
• 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

…and 5 more.