LinkSymphoKnee 880-217/10Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04026575253265), received between Jun 1, 2023 and Jun 1, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (4 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2023Positioning Failure; Positioning Failure

  LB WAS NOTIFIED ON (B)(6) 2022 BY J.B / T. R.: "AFTER ATTEMPTING TO IMPACT THE FINAL POLY SPACER, IT APPEARED TO HAVE BEEN LOCKED IN PLACE, BUT IN REDUCING THE KNEE INTO EXTENSION, THE POLY SEEMED DISASSOCIATED POSTERIOR FROM TIBIA IMPLANT (LOT # 1949231). THE SURGEON THEN REMOVED THE POLY AND REQUESTED A SECOND ONE (LOT # 1949232). WITH THE SECOND POLY AFTER APPEARED TO NOT LOCK IN THE BACK AFTER IMPACTING, THE SURGEON REQUESTED A THIRD POLY. AFTER CLEANING OUT SOFT TISSUE AND PLACING THE KNEE IN DEEP FLEXION, THE POLY LOCKED IN PLACE. AFTER CLOSING THE PATIENT AND PERFORMING ROM THE KNEE APPEARED TO BE STABLE AND THE SURGEON APPEARED TO BE SATISFIED WITH THE FUNCTION OF THE KNEE. THE PROCESSED ADDED ONLY A COUPLE OF MINUTES TO THE ENTIRE CASE." [CUSTOMER].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17043573 ↗
• MalfunctionJun 1, 2023Positioning Failure; Positioning Failure

  POSITIONING FAILURE OF ARTICULATING SURFACE IN THE TIBIAL COMPONENT. A DIFFERENT ARTICULATING SURFACE WAS USED INSTEAD. [CUSTOMER].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17040314 ↗
• MalfunctionJun 1, 2023Positioning Failure; Positioning Failure

  LB WAS NOTIFIED ON 2022-05-17 BY (B)(6).: "AFTER ATTEMPTING TO IMPACT THE FINAL POLY SPACER, IT APPEARED TO HAVE BEEN LOCKED IN PLACE, BUT IN REDUCING THE KNEE INTO EXTENSION, THE POLY SEEMED DISASSOCIATED POSTERIOR FROM TIBIA IMPLANT (LOT # 1949231). THE SURGEON THEN REMOVED THE POLY AND REQUESTED A SECOND ONE (LOT # 1949232). WITH THE SECOND POLY AFTER APPEARED TO NOT LOCK IN THE BACK AFTER IMPACTING, THE SURGEON REQUESTED A THIRD POLY. AFTER CLEANING OUT SOFT TISSUE AND PLACING THE KNEE IN DEEP FLEXION, THE POLY LOCKED IN PLACE. AFTER CLOSING THE PATIENT AND PERFORMING ROM THE KNEE APPEARED TO BE STABLE AND THE SURGEON APPEARED TO BE SATISFIED WITH THE FUNCTION OF THE KNEE. THE PROCESSED ADDED ONLY A COUPLE OF MINUTES TO THE ENTIRE CASE." [CUSTOMER]

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17040228 ↗
• MalfunctionJun 1, 2023Positioning Failure; Positioning Failure

  AS REPORTED TO LB ON 2022/06/28, PER K. N.: "ANOTHER POLY INSERT DIDN'T ENGAGE INTO TIBIAL BASE PLATE. ANOTHER POLY HAD TO BE USED INSTEAD." [CUSTOMER].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17040188 ↗

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-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-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-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.