MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-31 for PROFEMUR? RENAISSANCE? CLASSIC RDC FLARE SZ 10 V8D PLLER010 manufactured by Microport Orthopedics Inc..
[186558627]
This event will be updated once the investigation is complete. Trends will be evaluate.
Patient Sequence No: 1, Text Type: N, H10
[186558628]
Allegedly, patient undergoing left hip revision arthroplasty due to fracture of the femoral stem. Implanted products not revised: dynasty? Pc shell 50mm group c - product id: dspcgc50, lot number: 1555466. Cancellous 6. 5mm self-tapping bone screw 2. 0cm length - product id: 18080301, lot number: 1640236. Cancellous 6. 5mm self-tapping bone screw 1. 5cm length - product id: 18080300, lot number: 1641256.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010536692-2020-00296 |
| MDR Report Key | 9904117 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date Facility Aware | 2020-03-12 |
| Date Mfgr Received | 2020-03-12 |
| Date Added to Maude | 2020-03-31 |
| 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 | PROFEMUR? RENAISSANCE? CLASSIC RDC FLARE SZ 10 V8D |
| Generic Name | HIP COMPONENT |
| Product Code | JDI |
| Date Received | 2020-03-31 |
| Model Number | PLLER010 |
| Catalog Number | PLLER010 |
| Lot Number | 1558808 |
| 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 | 2020-03-31 |