MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2020-03-24 for EVOLUTION? MP? PS INSERT SIZE 3 STANDARD 10MM RIGH EIP3S10R manufactured by Microport Orthopedics Inc..
[184680487]
This event will be updated once the investigation is complete. Trends will be evaluated.
Patient Sequence No: 1, Text Type: N, H10
[184680488]
Allegedly, aseptic loosening, cs and ps type implants were included on both sides. Only ps was revised, patient had joint instability, the inserts had abnormal wear patterns and some discoloration. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010536692-2020-00257 |
| MDR Report Key | 9871663 |
| Report Source | FOREIGN |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-01-29 |
| Date Facility Aware | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-24 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | EVOLUTION? MP? PS INSERT SIZE 3 STANDARD 10MM RIGH |
| Generic Name | KNEE COMPONENT |
| Product Code | HRY |
| Date Received | 2020-03-24 |
| Returned To Mfg | 2020-03-10 |
| Model Number | EIP3S10R |
| Catalog Number | EIP3S10R |
| Lot Number | 1613489 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-24 |