Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
FDA adverse event reports and recall history for prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer (product code MBH), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 16,204
- Deaths
- 11
- Injuries
- 12,276
- Malfunctions
- 3,889
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 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.
- 2024-03-06Open, ClassifiedPackaging
X3 TRIATHLON CS INSERT NO 7 9 MM
Potential packaging breaches of inner blister and outer sterile blister.
Monitor prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer automatically
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