MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-03-06 for AMIS MOBILE LEG POSITIONER 01.15.10.0190 manufactured by Medacta International Sa.
[4336672]
While in surgery, the black wheel on the amis leg positioner began to make a grinding noise and it was also difficult to lock into place. As the days progressed it became increasingly difficult to use the black wheel and the locking mechanism. By the third surgery, the pt's foot had to be held and rotated manually. Reference mfr report # 3005180920-2014-00024.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006639916-2014-00024 |
| MDR Report Key | 3716307 |
| Date Received | 2014-03-06 |
| Date of Report | 2014-03-06 |
| Date of Event | 2014-02-03 |
| Date Facility Aware | 2014-02-03 |
| Report Date | 2014-03-06 |
| Date Reported to FDA | 2014-03-06 |
| Date Reported to Mfgr | 2014-03-06 |
| Date Added to Maude | 2014-04-02 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 1556 W CARROLL AVE |
| Manufacturer City | CHICAGO IL 606070000 |
| Manufacturer Country | US |
| Manufacturer Postal | 606070000 |
| Manufacturer G1 | MEDACTA USA INC. |
| Manufacturer Street | 1556 W CARROLL AVE |
| Manufacturer City | CHICAGO IL 60607000 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60607 0000 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMIS MOBILE LEG POSITIONER |
| Generic Name | LEG POSITIONER FOR HIP IMPLANTATION |
| Product Code | FWX |
| Date Received | 2014-03-06 |
| Catalog Number | 01.15.10.0190 |
| Lot Number | 1111566 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 25 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDACTA INTERNATIONAL SA |
| Manufacturer Address | CASTEL SAN PIETRO SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-03-06 |