LinkSymphoKnee 880-071/50Recalls & reported problems
WALDEMAR LINK GmbH & Co. KG · Femoral Component, PS · Class 2 · Implant
All models of LinkSymphoKnee (117)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04026575249794), received between Jul 11, 2025 and Jul 11, 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth1
- Patient-Device Incompatibility1
Patient problems
- Joint Laxity1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 11, 2025Patient-Device Incompatibility; Loosening of Implant Not Related to Bone-Ingrowth; Patient-Device Incompatibility; Loosening of Implant Not Related to Bone-Ingrowth
LINKBIO REVIEWED A PATIENT RECORD WHICH DESCRIBED REVISION OF THIS LINK KNEE (IMPLANTED (B)(6) 2023) ON (B)(6) 2023. THE OFFICE VISIT NOTE PRECEDING THE REVISION SURGERY (DATED (B)(6) 2023) INDICATES POSSIBLE PERIPROTHETIC LEFT KNEE INFECTION ASSOCIATED WITH CELLULITIS. COMMUNICATION FROM SURGEON INDICATES NO KNOWN INFECTION PRESENT FOR THIS REVISION. DR. WAS UNSURE OF THE CAUSE FOR ARTHROFIBROSIS BUT PATIENT PRESENTED WITH MULTI-DIRECTIONAL INSTABILITY. PATIENT'S LTT TESTING REFLECTS MILDLY REACTIVE TO ALUMINUM AND VANADIUM.
Patient problems: Joint Laxity
MAUDE report 22480033 ↗
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, ClassifiedLinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50
- Z-1701-2025 · Apr 3, 2025 · Open, ClassifiedL-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, ClassifiedPosterior 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, ClassifiedDistal 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-1702-2025 · Apr 3, 2025 · Open, ClassifiedTibial 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-1374-2025 · Feb 14, 2025 · Open, ClassifiedModular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13
- Z-1373-2025 · Feb 14, 2025 · Open, ClassifiedModular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12
- Z-1372-2025 · Feb 14, 2025 · Open, ClassifiedModular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11
- Z-1674-2023 · Apr 25, 2023 · Open, ClassifiedLINK 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, ClassifiedLinkSymphoKnee 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, ClassifiedLinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intended for primary and revision total knee replacement in skeletally mature patients.
Other PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices
- LinkSymphoKnee 880-307/21WALDEMAR LINK GmbH & Co. KG · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls2 reports
- Scorpio 73-3710Howmedica Osteonics Corp. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls1 report
- Scorpio 73-3110Howmedica Osteonics Corp. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls0 reports
- Arthrex® AR-503-TTTEArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall14 reports
- Arthrex® AR-503-TTTJArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall9 reports
- Arthrex® AR-503-TTTGArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- ENGAGE 1-10011-300Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- ENGAGE 1-10003-400Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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