LinkSymphoKnee 880-243/10Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04026575255344), received between Dec 3, 2024 and Jul 27, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

11 other recalls cover devices cleared under the same FDA submission (K202924); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Naturally Worn

  worn plateau "[customer]".

  Patient problems: Joint Laxity; Pain

  MAUDE report 50025828 ↗
• MalfunctionDec 5, 2024Positioning Failure; Positioning Failure

  DR. (B)(6) PERFORMED A REVISION FOR A POLY SWAP FOR A PATIENT WHO PRESENTED WITH DISCOMFORT. THE IMPLANT WAS ORIGINALLY DONE IN A BILATERAL PROCEDURE ON (B)(6) 20221. THE REVISION WAS COMPLETED ON (B)(6) 2024 TO THE RIGHT SIDE. ONLY THE POLY WAS REVISED. DR. (B)(6) THINKS THE POLYS ARE TOO THIN, THAT TOLERANCES AREN'T SUFFICIENT. THE ORIGINAL WAS A SIZE 10 CR BUT THE SWAP WAS WITH A SIZE 12 UC POLY. THE PATIENT ALSO HAS A SIZE 10 POLY ON THE LEFT SIDE AND HAS REPORTED SIMILAR DISCOMFORT. THE PART WILL NOT BE RETURNED FOR THE INVESTIGATION. [CUSTOMER]

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20852058 ↗
• InjuryDec 3, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  DR. DV PERFORMED A REVISION FOR A POLY SWAP FOR A PATIENT WHO PRESENTED WITH DISCOMFORT. THE IMPLANT WAS ORIGINALLY DONE IN A BILATERAL PROCEDURE ON (B)(6) 2022. THE REVISION WAS COMPLETED ON (B)(6) 2024 TO THE RIGHT SIDE. ONLY THE POLY WAS REVISED. THE ORIGINAL WAS A SIZE 10 CR BUT THE SWAP WAS WITH A SIZE 12 UC POLY. THE PATIENT ALSO HAS A SIZE 10 POLY ON THE LEFT SIDE AND HAS REPORTED SIMILAR DISCOMFORT.

  Patient problems: Implant Pain

  MAUDE report 20833020 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K202924. One submission often covers many models, so check the product and lot details in each record.

• Z-2541-2025 · Jul 31, 2025 · Open, Classified
  LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50
• Z-1701-2025 · Apr 3, 2025 · Open, Classified
  L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm), (2) 880-320/22 (Sz. 0 - cemented lg), (3) 880-321/12 (Sz. 1-2 - cemented sm), (4) 880-321/22 (Sz. 1-2
• Z-1702-2025 · Apr 3, 2025 · Open, Classified
  Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-331/13 (Sz. 1-2 - cemented md), (4) 880-331/21 (Sz. 1-2 - ce
• Z-1700-2025 · Apr 3, 2025 · Open, Classified
  Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3) 880-311/11 (Sz. 1-2 - cemented sm), (4) 880-311/21 (Sz. 1-2
• Z-1699-2025 · Apr 3, 2025 · Open, Classified
  Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 880-301/11 (Sz. 1-2 - cemented sm), (4) 880-301/21 (Sz. 1-2 -
• Z-1372-2025 · Feb 14, 2025 · Open, Classified
  Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11
• Z-1374-2025 · Feb 14, 2025 · Open, Classified
  Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13
• Z-1373-2025 · Feb 14, 2025 · Open, Classified
  Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12
• Z-1674-2023 · Apr 25, 2023 · Open, Classified
  LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for primary and revision total knee replacement. Item Number: 880-32
• Z-2067-2023 · Dec 23, 2022 · Open, Classified
  LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intended for primary and revision total knee replacement in skeletally mature patients.
• Z-2066-2023 · Dec 23, 2022 · Open, Classified
  LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for primary and revision total knee replacement in skeletally mature patients.