MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-10-19 for AMIS MOBILE LEG POSITIONER 2.0 FRAME 01.15.10.0190 manufactured by Medacta International Sa.
[124332463]
Batch review performed on 18 october 2018. Lot 1656236: (b)(4) items manufactured and released on 8 march 2018. No anomalies found related to the issue. To date, no similar event on the same lot has been registered. Additional item involved in the event: stem: amis-k 01. 20. 003 amis-k size 2s1 standard (not registered in us), lot 181278: (b)(4) items manufactured and released on 23 april 2017. Expiration date:2023-04-12. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been already sold without any similar reported event. Amis 01. 15. 10. 0315 amis shoe lot 1754696: (b)(4) items manufactured and released on 23 february 2018. No anomalies found related to the issue. To date, no similar event on the same lot has been registered. Clinical evaluation performed by medical affairs director: fracture of a femoral condyle was detected after primary tha with cemented femoral stem. The relationship between the fracture and the hip operation is unknown and quite unlikely. We see no possibility that this may have been caused by a faulty device.
Patient Sequence No: 1, Text Type: N, H10
[124332464]
Femoral condyle bone fracture discovered through the x-rays after hip surgery. It is unknown when the fracture occurred because no x-rays around the knee were taken before the surgery. The patient will be followed-up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005180920-2018-00801 |
| MDR Report Key | 7984644 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-10-19 |
| Date of Report | 2018-10-19 |
| Date of Event | 2018-09-19 |
| Date Mfgr Received | 2018-09-19 |
| Device Manufacturer Date | 2018-03-08 |
| Date Added to Maude | 2018-10-19 |
| 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, SWITZERLAND 6874 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 6874 |
| Manufacturer G1 | MEDACTA INTERNATIONAL SA |
| Manufacturer Street | STRADA REGINA |
| Manufacturer City | CASTEL SAN PIETRO, SWITZERLAND 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 MOBILE LEG POSITIONER 2.0 FRAME |
| Generic Name | SURGICAL INSTRUMENT FOR HIP SURGERIES |
| Product Code | LHX |
| Date Received | 2018-10-19 |
| Catalog Number | 01.15.10.0190 |
| Lot Number | 1656236 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDACTA INTERNATIONAL SA |
| Manufacturer Address | STRADA REGINA CASTEL SAN PIETRO, SWITZERLAND 6874 SZ 6874 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-19 |