Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Orthopedic · 21 CFR 888.3560
Recent MDR events
157,471 adverse event reports on file
- PERSONA FEM PS IMPACTOR PADJul 31, 2026MalfunctionZimmer Biomet, Inc.0001822565-2026-02724
- Unity Total Knee SystemJul 31, 2026InjuryCorin Ltd9614209-2026-00077
- UNK Knee Tibial InsertJul 31, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-13092
- P.F.C. SIGMAJul 31, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-13094
- P.F.C. SIGMAJul 31, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-13095
- Unknown NexGen Tibial TrayJul 31, 2026InjuryZimmer Biomet, Inc.0001822565-2026-02740
- TRITANIUM BPLATE TRIATHLON S1Jul 31, 2026InjuryStryker Orthopaedics-mahwah0002249697-2026-00659
- TRIATHLON P/A CR BEADED 1RJul 31, 2026InjuryStryker Orthopaedics-mahwah0002249697-2026-00658
- TRIATHLON PS X3 TIBIAL INSJul 31, 2026MalfunctionStryker Orthopaedics-mahwah0002249697-2026-00666
- DJO SURGICALJul 31, 2026InjuryEncore Medical L.p.1644408-2026-01453
Event type breakdown
Recalls
983 recall events for this product code
- United Orthopedic Corp.Open, ClassifiedAug 5, 2026
Brand Name: U2 Total Knee System
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Z-2883-2026 · View FDA record ↗ - Encore Medical, LPOpen, ClassifiedJul 8, 2026
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Description: Enovis knee devices are intended
Due to packaging discrepancy with incorrect product size mixed up.
Z-2700-2026 · View FDA record ↗ - Encore Medical, LPOpen, ClassifiedJul 8, 2026
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 341-14-711 Product Description: Enovis knee devices are for knee
Due to packaging discrepancy with incorrect product size mixed up.
Z-2701-2026 · View FDA record ↗ - Encore Medical, LPOpen, ClassifiedFeb 24, 2026
Brand Name: EMPOWR 3D KNEE
Knee and Humeral socket implants contain incorrect labeling.
Z-1459-2026 · View FDA record ↗ - Encore Medical, LPOpen, ClassifiedFeb 2, 2026
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
Z-1233-2026 · View FDA record ↗ - Waldemar Link GmbH & Co. KG (Mfg Site)Open, ClassifiedSep 8, 2025
LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50
Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
Z-2541-2025 · View FDA record ↗ - Encore Medical, LPOpen, ClassifiedAug 8, 2025
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS
Knee implants contain incorrect labeling (size and/or side incorrect)
Z-2285-2025 · View FDA record ↗ - Encore Medical, LPOpen, ClassifiedAug 8, 2025
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS
Knee implants contain incorrect labeling (size and/or side incorrect)
Z-2286-2025 · View FDA record ↗ - Encore Medical, LPOpen, ClassifiedJul 17, 2025
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS
Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.
Z-2125-2025 · View FDA record ↗ - Encore Medical, LPOpen, ClassifiedJul 17, 2025
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS
Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.
Z-2126-2025 · View FDA record ↗
Registered firms
3,452 firms currently registered for this product code
Ppd Meditech, Div. Of Industries Ppd Inc.
Waterville Quebec, CA
Millstone Medical Outsourcing Llc.
FALL RIVER, MA, US
Zimmer Pte. Ltd.
Singapore South East, SG
Zimmer Biomet Korea Ltd.
Seoul, KR
Oberg Medical Products Company
Sarver, PA, US
Bgs Beta-gamma-service Gmbh & Co Kg
Wiehl North Rhine-Westphalia, DE
Uoc Usa Inc.
Irvine, CA, US
Jarvis Surgical Inc.
Westfield, MA, US
Depuy (ireland)
CO. CORK Munster, IE
Exactech Sarasota
Sarasota, FL, US
Isomedix Operations Inc.
Northborough, MA, US
Sterigenics Us Llc
West Memphis, AR, US
Avalign Instruments & Implants
FORT WAYNE, IN, US
Materialise Sdn Bhd
Petaling Jaya Selangor, MY
Materialise Ukraine, Rep. Office
Kyiv Kyyiv, Misto, UA
Zimmer (shanghai) Medical International Trading Co., Ltd.
Shanghai, CN
Biopro, Inc.
PORT HURON, MI, US
Rms Surgical
Anoka, MN, US
Sterigenics U.s., Llc
Atlanta, GA, US
Isomedix Operations, Inc.
Libertyville, IL, US
Zimmer, Inc.
WARSAW, IN, US
United Orthopedic Corp.
Kaohsiung, TW
Sterigenics Us Llc
Fort Worth, TX, US
510(k) clearances
915 clearances for this product code
- Maxx Orthopedics, Inc.Aug 7, 2026
K261563 · Freedom Total Knee System (E-Poly Tibial Liners)
- Globus Medical, Inc.Jul 31, 2026
K262251 · ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)
- Total Joint Orthopedics, Inc.Jul 23, 2026
K261734 · Klassic Infection Spacer System
- DePuy Ireland UCJun 25, 2026
K261458 · ATTUNE Total Knee System; ATTUNE Cementless Knee System
- NovoSourceApr 27, 2026
K261032 · NovoKnee (SteriKnee)
- Materialise NVJan 6, 2026
K253793 · Materialise TKA Guide System
- Encore Medical L.P.Dec 19, 2025
K252974 · EMPOWR Knee
- Depuy Ireland UCNov 19, 2025
K253197 · ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors