Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.

Recent recalls

• 2026-09-16Open, ClassifiedProcess change control

  SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 3045-0032 Orthopaedic implant components manufactured from UHMWPE (polyethylene)

  Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

• 2026-06-24Open, ClassifiedLabeling Change Control

  Brand Name: Persona Revision Product Name: Persona Revision Trabecular Metal Femoral Distal Augment Model/Catalog Number: 42-5572-066-10 Software Version: N/A Product Description: Persona Revision Trabecular Metal Femoral Distal Augment Size 9, 9+ 10mm Thicknes Component: N/A

  Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.

• 2026-06-17Open, ClassifiedUnder Investigation by firm

  TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.

  Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).

• 2026-06-17Open, ClassifiedUnder Investigation by firm

  TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.

  Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).

• 2024-12-18Open, ClassifiedLabeling Change Control

  EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPONENT CS/CR NON-POROUS SIZE 6 LEFT PRIMARY, REF: EFSRN6PL Knee prosthesis component

  Femoral implant porous size 5 right primary and femoral implant non-porous size 6 left primary have correct markings on devices, but may have incorrect packaging.

• 2024-04-22Open, ClassifiedProcess change control

  Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packaging in the form of a polyurethane bag, and sealed closed (inner barrier). The inner barrier is then placed into a PETG tray and sealed with Tyvek lid stock (outer barrier). The sealed double barrier system is placed into a paperboard carton with an IFU and label/indicator dots applied to the carton.

  Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.

• 2024-03-29Open, ClassifiedProcess change control

  ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.

  Product incorrectly labelled.

• 2024-03-06Open, ClassifiedPackaging

  X3 TRIATHLON CS INSERT NO 3 10 MM

  Potential packaging breaches of inner blister and outer sterile blister.

• 2024-03-06Open, ClassifiedPackaging

  X3 TRIATHLON CS INSERT NO 6 10 MM

  Potential packaging breaches of inner blister and outer sterile blister.

• 2024-03-06Open, ClassifiedPackaging

  X3 TRIATHLON CS INSERT NO 6 11 MM

  Potential packaging breaches of inner blister and outer sterile blister.