LinkSymphoKnee 880-081/40Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04026575250530), received between Jul 8, 2025 and Jul 8, 2025 — classified as 1 injury.

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 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.

• InjuryJul 8, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IN A LETTER DATED 04-FEB-2025, THE SURGEON STATED THAT THE PATIENT, WHO IS ALLERGIC TO COBALT AND CEMENT, HAS A PAINFUL LEFT KNEE WITH AN EXISTING REVISION CONSTRUCT (CEMENTED FEMUR, CEMENTLESS STEMS), AND AFTER IMAGING REVIEW AND PATIENT EXAMINATION, IT APPEARS THE PAIN IS ASSOCIATED WITH LOOSENING OF THE CURRENT IMPLANT. SURGEON ADVISES THAT THERE WAS NOT A LARGE ENOUGH STEM AVAILABLE FOR ADEQUATE PRESS FIT, AND THE INFLAMMATORY REACTION THE PATIENT HAD FROM A CHRONIC INFECTION CAUSED IT TO LOOSEN EARLY. REVISION OF THE FEMORAL COMPONENT IS PLANNED.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 22440788 ↗

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-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-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-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-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-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-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-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-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.
• 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.