MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-12-16 for AMIS LEG POSITIONER 01.15.10.0190 manufactured by Medacta International Sa.
[62601269]
Additional information received from the initial reporter on (b)(6) 2016 and includes: the nurse was? Expert? And used to manipulate the leg positioner but first the rotation was uneasy and then probably happened the fracture. However they finally noticed the fracture at the end of the intervention during the reduction. The fracture was fixed during the same intervention. On (b)(6) 2016 the medical affairs director performed a clinical evaluation and commented as follows: the succession of events is not very clear: apparently, a tibial fracture was generated during the tha operation in a very osteoporotic patient (according to report), possibly during the external rotation of the limb. This operation is done manually by an or help, normally. It is not clear how and why medacta devices would be responsible for this event. No final conclusion can be drawn with the information currently available. Batch reviews performed on (b)(6) 2016. Amis mobile leg positioner 2. 0, code 01. 15. 10. 0190, lot. 1411958 one item manufactured and released on (b)(6) 2014. No anomalies found related to the problem. Amis shoe, code 01. 15. 10. 0315 lot 1551837: the 30 items manufactured and released on (b)(6) 2015. No anomalies found related to the problem. To date, no similar events have been reported on items of the same lot.
Patient Sequence No: 1, Text Type: N, H10
[62601270]
At the end of the hip surgery it was noticed that the tibia around malleolus of the patient was fractured. The nurses in the or first had a hard maneuver with external rotation.
Patient Sequence No: 1, Text Type: D, B5
[70218133]
On 13 march 2017 the r&d project manager performed a visual inspection of the retrieved item and commented as follows: following visual and functional checks of the item, no improprierties were found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005180920-2016-00669 |
| MDR Report Key | 6180744 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-12-16 |
| Date of Report | 2017-03-17 |
| Date of Event | 2016-11-18 |
| Date Mfgr Received | 2016-11-18 |
| Device Manufacturer Date | 2014-11-27 |
| Date Added to Maude | 2016-12-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 Contact | MR. STEFANO BAJ |
| Manufacturer Street | STRADA REGINA |
| Manufacturer City | CASTEL SAN PIETRO, 6874 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 6874 |
| Manufacturer Phone | 91 6966060 |
| Manufacturer G1 | MEDACTA INTERNATIONAL SA |
| Manufacturer Street | STRADA REGINA |
| Manufacturer City | CASTEL SAN PIETRO, 6874 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6874 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMIS LEG POSITIONER |
| Generic Name | TABLE FOR SURGERY |
| Product Code | FWX |
| Date Received | 2016-12-16 |
| Returned To Mfg | 2017-02-24 |
| Catalog Number | 01.15.10.0190 |
| Lot Number | 1411958 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDACTA INTERNATIONAL SA |
| Manufacturer Address | STRADA REGINA CASTEL SAN PIETRO, 6874 SZ 6874 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-12-16 |