Table 2.
Summary of adverse events in the MAUDE database according to subgroups and TAR devices
| Subgroups | Stryker | Wright Medical | Zimmer | Salto Talaris | Agility | Cadence | Exactech | Subtotal |
|---|---|---|---|---|---|---|---|---|
| Aseptic loosening | 83 | 21 | 9 | 11 | 1 | n/a | 125 (19.6%) | |
| Infection | 56 | 16 | 22 | 17 | n/a | 3 | 4 | 118 (18.5%) |
| Alignment/mechanical | 66 | 16 | 13 | 3 | 6 | 1 | 2 | 107 (16.8%) |
| Implant/instrumentation | 32 | 34 | 4 | 1 | 1 | 1 | n/a | 73 (11.4%) |
| Impingement | 33 | 2 | 12 | 12 | 1 | n/a | n/a | 60 (9.4%) |
| Polyethylene related | 40 | n/a | n/a | n/a | n/a | n/a | 1 | 41 (6.4%) |
| Fractures | 19 | 4 | 2 | 3 | n/a | 7 | 1 | 36 (5.6%) |
| Avascular necrosis-Talus | 7 | n/a | 1 | n/a | n/a | n/a | 8 (1.3%) | |
| Packaging/availability | 2 | n/a | 1 | n/a | n/a | n/a | 3 (0.5%) | |
| Others | Posterior tibial-tendinosis (1) SPN palsy (1) PE (2) Amputation (1) Death (1) | n/a | Peroneal tendinosis (1) Allergic reaction (1) Nonunion of fibula (4) Plate breakage (1) | n/a | n/a | n/a | n/a | 13 (2%) |
| Unspecified | 21 | 20 | 5 | 4 | 4 | n/a | n/a | 54 (8.5%) |
| Total reports | 365 | 113 | 76 | 51 | 13 | 12 | 8 | 638 |
n/a not available, PE pulmonary embolism, SPN superficial peroneal nerve