MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-21 for MOTO PARTIAL KNEE TIBIAL INSERT FIX S7 LM - 9MM 02.18.IF7.09.LM manufactured by Medacta International Sa.
[188737672]
Batch review performed on 03 february 2020: lot 168031: (b)(4) items manufactured and released on 16-feb-2017. Expiration date: 2022-01-30. 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 since 1-1-2016.
Patient Sequence No: 1, Text Type: N, H10
[188737673]
The patient complained that his knee felt "loose". All components were well fixed and the poly used in the primary case was in good condition when removed. 1 year and 4 months after primary the poly has been upsized to give the patient more stability in the knee.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005180920-2020-00080 |
| MDR Report Key | 9738636 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-01-22 |
| Date Mfgr Received | 2020-01-22 |
| Device Manufacturer Date | 2017-02-16 |
| Date Added to Maude | 2020-02-21 |
| 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 TIBIAL INSERT FIX S7 LM - 9MM |
| Generic Name | KNEE IMPLANT: TIBIAL INSERT FIXED |
| Product Code | HSX |
| Date Received | 2020-02-21 |
| Model Number | 02.18.IF7.09.LM |
| Catalog Number | 02.18.IF7.09.LM |
| Lot Number | 168031 |
| 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 | 2020-02-21 |