MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-16 for CS INSRT IMPL SZ 3 LEFT 10MM IMPLANT PARTNERS? EAI3110LWD manufactured by Microport Orthopedics Inc..
[183882405]
This event will be updated once the investigation is complete. Trends will be evaluate.
Patient Sequence No: 1, Text Type: N, H10
[183882406]
Allegedly, the patient was implanted with the evolution nitrix (tibial and femoral components) but surgery was completed without a tibia insert because the hospital only had implant partner inserts available which are not indicated for use with the evolution nitrix. The insert was later implanted which would work with the tibial and femoral components. There was a secondary surgery due to a non-compatible insert for the original surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010536692-2020-00239 |
| MDR Report Key | 9835696 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Date Facility Aware | 2020-02-27 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-16 |
| 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 Street | 5677 AIRLINE ROAD |
| Manufacturer City | ARLINGTON TN 38002 |
| Manufacturer Country | US |
| Manufacturer Postal | 38002 |
| Manufacturer Phone | 9018674771 |
| Manufacturer G1 | MICROPORT ORTHOPEDICS INC. |
| Manufacturer Street | 5677 AIRLINE RD. |
| Manufacturer City | ARLINGTON TN 38002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CS INSRT IMPL SZ 3 LEFT 10MM IMPLANT PARTNERS? |
| Generic Name | KNEE COMPONENT |
| Product Code | HRY |
| Date Received | 2020-03-16 |
| Model Number | EAI3110LWD |
| Catalog Number | EAI3110LWD |
| Lot Number | 15220061596738. |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROPORT ORTHOPEDICS INC. |
| Manufacturer Address | 5677 AIRLINE RD. ARLINGTON TN 38002 US 38002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-16 |