MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-02-12 for MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S6 RM 02.18.006RM manufactured by Medacta International Sa.
[178756419]
Batch review performed on 22. 01. 2020: lot 167879: (b)(4) items manufactured and released on 15. 02. 2017. Expiration date: 2022-02-06. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2016. Other devices involved in the event. Moto partial knee 02. 18. Tf5. Rm tibial tray fix cemented s5 rm lot. 167759 (k162084). Batch review performed on 22. 01. 2020: lot 167759: (b)(4) items manufactured and released on 21. 02. 2017. Expiration date: 2022-02-07. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2016. Moto partial knee 02. 18. If5. 08. Rm tibial insert fix s5 rm 8mm lot. 167817 (k162084). Batch review performed on 22. 01. 2020: lot 167817: (b)(4) items manufactured and released on 03. 01. 2017. Expiration date: 2021-12-01. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been already sold with one similar reported event since 2016.
Patient Sequence No: 1, Text Type: N, H10
[178756420]
Revision surgery performed 9 months after the primary due to signs of an infection and the pathogen is unknown. The surgeon removed the femoral component, tibial tray, and insert and implanted a femur, patella and liner. The surgeon will wait for the infection to clear before implanting permanent hardware.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005180920-2020-00041 |
| MDR Report Key | 9698646 |
| Report Source | OTHER |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-12 |
| Date of Event | 2020-01-14 |
| Date Mfgr Received | 2020-01-13 |
| Device Manufacturer Date | 2017-02-15 |
| Date Added to Maude | 2020-02-12 |
| 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, 6874 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6874 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S6 RM |
| Generic Name | PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED |
| Product Code | HSX |
| Date Received | 2020-02-12 |
| Model Number | 02.18.006RM |
| Catalog Number | 02.18.006RM |
| Lot Number | 167879 |
| 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, 6874 SZ 6874 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-12 |