Recall Z-2941-2020 ยท LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
MicroPort Orthopedics Inc.
PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hip prosthesis component.
| Date | Sep 18, 2020 (initiated Jul 31, 2020) |
| Status | Terminated |
| Reason | MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long Titanium modular femoral neck component after implantation. Worldwide there were 680 Long and X-Long PROFEMUR Titanium modular neck fractures among 123,840 global sales representing is a cumulative rate of modular neck device fracture of 0.55% from 2002 to 2019. Within the United States there were 349 Long and X-Long PROFEMUR Titanium modular neck fractures among 15,786 United States sales representing a cumulative rate of modular neck device fracture with a fracture rate in the United Stat |
| Root cause | Device Design |
| Action | The firm initiated the recall by letter on 07/31/2020. The letter provide the following instructions: "Distributors: 1. Please immediately cease use and distribution of these products. 2. Please check your stock, including all consignment stock to immediately determine if you have any affected product. 3. Please complete the form on the last page of this notification and return the form and any affected products to MicroPort Orthopedics per the Actions section of this notification. 4. Please assist us by distributing this notification to all hospitals and surgeons in your territory and |
| Quantity | 123,284 units |
| Distribution | worldwide, except China and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003016 | PRO-FEMUR R Wrightmedicaltechnologyinc, Dec 13, 2000 |