MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-20 for MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S5 RM 02.18.005RM manufactured by Medacta International Sa.
[188735527]
Batch review performed on 27 january 2020: lot 163687: (b)(4) items manufactured and released on 24-oct-2016. Expiration date: 2021-06-21. 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. Other devices involve in the event: moto partial knee 02. 18. Tf6. Rm tibial tray fix cemented s6 rm lot. 167760 (k162084) batch review performed on 27 january 2020 lot 167760: (b)(4) items manufactured and released on 15-feb-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. Moto partial knee 02. 18. If6. 09. Rm tibial insert fix s6 rm - 9mm lot. 172322 (k162084) batch review performed on 27 january 2020 lot 172322: 34 items manufactured and released on 15-feb-2017. Expiration date: 2022-02-07. No anomalies found related to the problem. To date, 8 items of the same lot have been already sold without any other similar reported event.
Patient Sequence No: 1, Text Type: N, H10
[188735528]
The patient came in due to signs of an infection and the pathogen is unknown. The surgeon removed all components and implanted an antibiotic spacer 2 weeks after previous surgery. The surgery was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005180920-2020-00073 |
| MDR Report Key | 9731551 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-01-07 |
| Date Mfgr Received | 2020-01-21 |
| Device Manufacturer Date | 2016-10-24 |
| Date Added to Maude | 2020-02-20 |
| 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 S5 RM |
| Generic Name | ANATOMICAL FEMORAL COMPONENT CEMENTED |
| Product Code | HSX |
| Date Received | 2020-02-20 |
| Model Number | 02.18.005RM |
| Catalog Number | 02.18.005RM |
| Lot Number | 163687 |
| 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 | 2020-02-20 |