MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-13 for CONSERVE? TOTAL A-CLASS? HEAD 38AM-5004 manufactured by Microport Orthopedics Inc..
[183513596]
Allegedly the patient was experiencing adverse tissue reaction. (right). (b)(4). Additional information on 02/13/2020: revision surgery date confirmed on (b)(6) 2020 due to bone scan confirmed prosthetic cup loosening.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3010536692-2020-00232 |
MDR Report Key | 9828866 |
Date Received | 2020-03-13 |
Date of Report | 2020-03-13 |
Date of Event | 2019-10-25 |
Date Facility Aware | 2020-02-13 |
Date Added to Maude | 2020-03-13 |
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? TOTAL A-CLASS? HEAD |
Generic Name | HIP COMPONENT |
Product Code | JDL |
Date Received | 2020-03-13 |
Model Number | 38AM-5004 |
Catalog Number | 38AM-5004 |
Lot Number | 039808004 |
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 | 2020-03-13 |