MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-02-19 for CONSERVE? RESURFACING FEMORAL HEAD 50MM 38XXXX50 manufactured by Microport Orthopedics Inc..
[182523705]
This event will be updated once the investigation is complete. Trends will be evaluate.
Patient Sequence No: 1, Text Type: N, H10
[182523706]
Allegedly, in 2009 the patient developed left iliopsoas insufficiency and left hip flexion weakness. In 2018 there was evidence of fluid collection around the hip area, early tendon attrition, and urine cobalt levels of 12. 4 mcg/l and blood cobalt levels of 2, 6 mcg/l. The patient also had evidence of neurologic affectation suggesting chronic toxic encephalopathy and adverse reaction to metallic debris. Upon revision it was found a cystic pseudotumor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010536692-2020-00140 |
| MDR Report Key | 9726784 |
| Report Source | OTHER |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-19 |
| Date of Event | 2018-12-10 |
| Date Facility Aware | 2020-02-03 |
| Date Mfgr Received | 2020-02-03 |
| Date Added to Maude | 2020-02-19 |
| 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 | CONSERVE? RESURFACING FEMORAL HEAD 50MM |
| Generic Name | HIP COMPONENT |
| Product Code | JDL |
| Date Received | 2020-02-19 |
| Model Number | 38XXXX50 |
| Catalog Number | 38XXXX50 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-02-19 |