Table 1.
Overview of the characteristics of medical device reporting (MDR) data reported between 1 January 2008 and 31 December 2017
| Manufacturer | Number of MDRs (% of total) |
|---|---|
| Depuy Johnson & Johnson | 1528 (64.28) |
| Stryker | 546 (22.97) |
| Wright Medical Technology | 192 (8.08) |
| Smith & Nephew | 46 (1.94) |
| Zimmer | 42 (1.77) |
| Exactech | 12 (0.51) |
| Encore Medical | 8 (0.34) |
| Stelkast | 3 (0.13) |
| Device Problem | |
| Known | 1309 (55.07) |
| Unknown | 1068 (44.93) |
| Known Device Problem | n = 1309 |
| Fracture/break/crack/scratched material | 518 (39.57) |
| Dislodged/dislocated/displaced/disassembly/malposition/migration or expulsion of device | 149 (11.38) |
| Loss of osseointegration/failure to bond | 110 (8.40) |
| Component issue/connection issue/implant loose fitting issues/inadequacy of device shape/size/ | 34 (2.60) |
| Material corrosion/degradation/integrity/deformation/naturally worn | 25 (1.91) |
| Metal shedding debris | 8 (0.61) |
| Other | 465 (35.52) |
| Type of Event | |
| Death | 2 (0.08) |
| Serious injury | 1714 (72.11) |
| Malfunction (no serious injury) | 653 (27.47) |
| Other | 4 (0.17) |
| Unknown | 4 (0.17) |
| Country of Origin | |
| United States | 1807 (76.02) |
| Foreign (rest of the world excluding United States) | 514 (21.62) |
| Unknown | 56 (2.36) |
| Report Source Code | |
| Manufacturer | 2377 |
| User facility | 0 |
| Distributor | 0 |
| Voluntary | 0 |
| Reporter Occupation | |
| Physician | 913 (38.41) |
| Health professional other than physician | 445 (18.72) |
| Attorney | 89 (3.75) |
| Patient | 28 (1.94) |
| Risk manager | 14 (1.77) |
| Pharmacist | 7 (0.30) |
| Company technician/representative | 7 (0.30) |
| Others | 752 (31.64) |
| Unknown | 122 (5.13) |
| Device Availability | |
| Yes | 627 (26.38) |
| No | 1716(77.19) |
| Unknown | 34 (1.43) |
| Device Evaluated by Manucturer a (out of the available devices) | |
| Yes | 423 (67.46) |
| No | 88 (14.04) |
| Unknown | 116 (18.50) |
| Remedial Action | |
| Other | 630 (39.12) |
| Recall | 3 (0.12) |
| Modification/adjustment | 1 (0.04) |
| Blank | 1743 (73.33) |
| Recalls‐Removal Correction Number | |
| Z‐1749/1816‐2011 (Depuy Johnson & Johnson) | 2 (66.67) |
| Blank (Depuy Johnson & Johnson) | 1 (33.33) |
a
The device can only be evaluated by the manufacturer if it is available.