Endo-Model Modular Knee Prosthesis System 15-3816/11Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04026575034741), received between Nov 2, 2022 and Feb 6, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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.

• InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Positioning Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  IN A REQUEST FORM FROM DR. M FOR COMPASSION USE REVISION, REFERENCE (B)(4), THE DOCTOR MENTIONS THAT HE SUSPECTED THAT THE POLY AUGMENTS IMPLANTED ON (B)(6) 2021, MAY BE LOOSE. RECEIVED THE POST-OP REPORT ON 01/10/2025, STATING THAT THE TIBIAL COMPONENT SHOWED EVIDENCE OF LOOSENING, THE FEMORAL COMPONENT DID NOT. THE TIBIAL COMPONENT WAS UNDERCUT BELOW THE LEVEL OF THE POLY AUGMENT. REVISION WITH (B)(4) WAS COMPLETED ON OCT. 2, 2024. UNKNOWN DATE OF EVENT. PRE-OP AND POST-OP IMAGING HAS BEEN REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 21320855 ↗
• InjuryAug 23, 2023Detachment of Device or Device Component; Patient Device Interaction Problem; Detachment of Device or Device Component; Patient Device Interaction Problem

  TINBN-COATED HINGED KNEE WAS IMPLANTED (B)(6) 2022 AS A TEMPORARY SPACER FOR THE 1ST STAGE IN A PLANNED 2 STAGE REVISION FOR INFECTION. THIS TINBN-COATED HINGED KNEE WAS USED AS A SPACER BECAUSE OF THE PATIENT'S NICKEL ALLERGY. THE PATIENT UNDERWENT REVISION SURGERY (B)(6) 2022. THE FEMORAL COMPONENT, TIBIAL POLYETHYLENE BEARING, AND FEMORAL AUGMENT WERE REPLACED (IMPACTED ONTO THE EXISTING FEMORAL STEM IN SITU). PRIOR SURGERIES ON THIS KNEE INCLUDE: PRIMARY AND REVISION TKA (NOT LINK PRODUCT), REVISION WITH LINK COMPASSIONATE USE COMPONENTS (B)(6) 2022 (B)(4), AND SUBSEQUENT REVISIONS (B)(6) 2022 AND (B)(6) 2022 FOR INFECTION (PREVIOUSLY REPORTED IN COMPLAINT (B)(4). [CUSTOMER].

  Patient problems: Failure of Implant; Hypersensitivity/Allergic reaction

  MAUDE report 17602033 ↗
• InjuryAug 23, 2023Detachment of Device or Device Component; Patient Device Interaction Problem; Detachment of Device or Device Component; Patient Device Interaction Problem

  TINBN-COATED HINGED KNEE WAS IMPLANTED (B)(6) 2022 AS A TEMPORARY SPACER FOR THE 1ST STAGE IN A PLANNED 2 STAGE REVISION FOR INFECTION. THIS TINBN-COATED HINGED KNEE WAS USED AS A SPACER BECAUSE OF THE PATIENT'S NICKEL ALLERGY. THE PATIENT UNDERWENT REVISION SURGERY (B)(6) 2022. THE FEMORAL COMPONENT, TIBIAL POLYETHYLENE BEARING, AND FEMORAL AUGMENT WERE REPLACED (IMPACTED ONTO THE EXISTING FEMORAL STEM IN SITU). PRIOR SURGERIES ON THIS KNEE INCLUDE: PRIMARY AND REVISION TKA (NOT LINK PRODUCT), REVISION WITH LINK COMPASSIONATE USE COMPONENTS (B)(6)2022(COMP(B)(4)), AND SUBSEQUENT REVISIONS (B)(6) 2022 AND (B)(6) 2022 FOR INFECTION (PREVIOUSLY REPORTED IN COMPLAINT (B)(4)). [CUSTOMER]

  Patient problems: Failure of Implant; Hypersensitivity/Allergic reaction; Pain

  MAUDE report 17602032 ↗
• InjuryAug 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS TINBN-COATED HINGED KNEE WAS IMPLANTED ON (B)(6) 2022 AS A TEMPORARY SPACER FOR THE 1ST STAGE IN A PLANNED 2 STAGE REVISION FOR INFECTION. THIS TINBN-COATED HINGED KNEE WAS USED AS A SPACER BECAUSE OF THE PATIENT'S NICKEL ALLERGY. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022. OPERATIVE FINDING WAS "WHAT APPEARED TO BE A DISASSOCIATED COMPONENT, WHICH WAS UNCLEAR AS TO THE SOURCE." DISASSOCIATION WAS BETWEEN THE DISTAL FEMORAL COMPONENT AND THE FEMORAL STEM. THE FEMORAL COMPONENT, TIBIAL POLYETHYLENE BEARING, AND FEMORAL AUGMENT WERE REPLACED (IMPACTED ONTO THE EXISTING FEMORAL STEM IN SITU). PRIOR SURGERIES ON THIS KNEE INCLUDE: PRIMARY AND REVISION TKA (NOT LINK PRODUCT), REVISION WITH LINK COMPASSIONATE USE COMPONENTS ON (B)(6) 2022 (B)(4), AND SUBSEQUENT REVISIONS ON (B)(6) 2022 FOR INFECTION (PREVIOUSLY REPORTED IN COMPLAINT (B)(4)).

  Patient problems: Joint Laxity

  MAUDE report 17447167 ↗
• InjuryAug 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS TINBN-COATED HINGED KNEE WAS IMPLANTED (B)(6) 2022 (FEMORAL COMPONENTS AND TIBIAL PLATEAU) AND (B)(6) 2022 (TIBIAL TRAY AND STEM) AS A TEMPORARY SPACER FOR THE 1ST STAGE IN A PLANNED 2 STAGE REVISION FOR INFECTION (WITH DEFINITIVE PROSTHESIS TO BE CUSTOM-MADE BY ANOTHER SUPPLIER). THIS TINBN-COATED HINGED KNEE WAS USED AS A TEMPORARY SPACER BECAUSE OF THE PATIENT'S NICKEL ALLERGY. THE PATIENT PRESENTED TO THE ER AND UNDERWENT REVISION SURGERY (B)(6) 2023 DUE TO DISSOCIATION OF THE FEMORAL COMPONENT FROM FEMORAL STEM. THE FEMORAL STEM, FEMORAL AUGMENT, FEMORAL COMPONENT, AND TIBIAL PLATEAU WERE REPLACED, WITH THE CONSTRUCT STILL BEING INTENDED AS A TEMPORARY SPACER, ANTICIPATING LATER CONVERSION TO DEFINITIVE CUSTOM-MADE IMPLANTS. PRIOR SURGERIES ON THIS KNEE INCLUDE: PRIMARY AND REVISION TKA (NOT LINK PRODUCT), REVISION WITH LINK COMPASSIONATE USE COMPONENTS (B)(6) 2022 ((B)(4)), AND SUBSEQUENT REVISIONS (B)(6) 2022 AND (B)(6) 2022 FOR INFECTION (PREVIOUSLY REPORTED IN COMPLAINT (B)(4)) AND FOR DISSOCIATION OF FEMORAL COMPONENT FROM STEM (SAME STEM AS PREVIOUS EVENT IN COMPLAINT (B)(4)).

  Patient problems: Joint Laxity

  MAUDE report 17445501 ↗
• InjuryNov 2, 2022Component Missing; Detachment of Device or Device Component; Component Missing; Detachment of Device or Device Component

  PE PLATEAU DISPLACED.

  Patient problems: Failure of Implant

  MAUDE report 15713679 ↗

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

…and 5 more.