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Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

Open-data reference.

FDA MAUDE adverse event data · 2016–2026

What the Data Shows About Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

The FDA MAUDE database aggregates 548 adverse-event reports for Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant spanning the period from 2016 through 2026. Of these, 0 are classified as death reports, 528 as injury reports, and 20 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 2 distinct event types and 9 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 20 distinct product-problem codes appear in the reports, with Adverse Event Without Identified Device or Use Problem topping the list at 323 reports. Reports are associated with 10 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 11 years of MAUDE data, with the peak single-year volume reaching 257 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 3 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on . This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.

548
Total Reports
0
Death Reports
528
Injury Reports
20
Malfunctions

Event Types

Injury 528 (96.4%)
Malfunction 20 (3.6%)

Patient Outcomes

Required Intervention 376 (62.4%)
Other 140 (23.2%)
R 31 (5.1%)
Disability 16 (2.7%)
Hospitalization 13 (2.2%)
S 11 (1.8%)
O 9 (1.5%)
H 5 (0.8%)
2 (0.3%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 323
Insufficient Information 54
Migration 40
Osseointegration Problem 32
Implant subsidence 29
Unintended Movement 14
Degraded 13
Material Fragmentation 10
Patient Device Interaction Problem 9
Loosening of Implant Not Related to Bone-Ingrowth 8
Therapeutic or Diagnostic Output Failure 7
Malposition of Device 6
Material Integrity Problem 6
Break 5
Collapse 4
Device Dislodged or Dislocated 4
Fracture 4
Naturally Worn 4
Patient-Device Incompatibility 4
Appropriate Term/Code Not Available 2

Yearly Trend

16
2016: 1
17
2017: 7
18
2018: 13
19
2019: 44
20
2020: 36
21
2021: 28
22
2022: 94
23
2023: 19
24
2024: 41
25
2025: 257
26
2026: 8

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Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a device is unsafe — higher-use devices naturally generate more reports.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from the FDA MAUDE database. Consult a qualified professional before making decisions based on this data.