MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-08 for MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S2 RM 02.18.002RM manufactured by Medacta International Sa.
[174858043]
Batch review performed on 20 december 2019. Lot 189248:(b)(4) items manufactured and released on 23-jan-2019. Expiration date: 2024-01-10. 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. Other devices involved in the event: moto partial knee 02. 18. If2. 09. Rm tibial insert fix s2 rm - 8mm lot. 168049 (k162084). Batch review performed on 20 december 2019. Lot 168049: (b)(4) items manufactured and released on 17-jan-2017. Expiration date: 2021-12-18. 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. Moto partial knee 02. 18. Tf2. Rm tibial tray fix cemented s2 rm lot. 184276 (k162084). Batch review performed on 20 december 2019. Lot 184276: (b)(4) items manufactured and released on 02-oct-2018. Expiration date: 2023-09-19. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been already sold with one other similar event reported.
Patient Sequence No: 1, Text Type: N, H10
[174858044]
Revision surgery performed after 5 months from the primary due to instability due to a stiff knee. The cause of the stiff knee is unknown. The surgeon revised the femoral component, tibial tray, and insert and the surgery was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005180920-2019-01112 |
| MDR Report Key | 9562264 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-08 |
| Date of Report | 2020-01-08 |
| Date of Event | 2019-12-09 |
| Date Mfgr Received | 2019-12-09 |
| Device Manufacturer Date | 2019-01-23 |
| Date Added to Maude | 2020-01-08 |
| 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 S2 RM |
| Generic Name | PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED |
| Product Code | HSX |
| Date Received | 2020-01-08 |
| Catalog Number | 02.18.002RM |
| 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 | 2020-01-08 |