MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2020-03-17 for PROFEMUR? MODULAR FEMORAL NECK PHA01232 manufactured by Microport Orthopedics Inc..
[183924536]
This event will be updated once the investigation is complete. Trends will be evaluated.
Patient Sequence No: 1, Text Type: N, H10
[183924537]
Allegedly, on (b)(6) 2019 patient was notified that she suffered pseudotumor in her left hip, with concern about friction, corrosion and failure of her profemur modular neck, as well as concern over migration of the dynasty liner.. The structural failure of the titanium profemur modular neck components was the result of a fatigue failure of the titanium, caused over time by cyclic loading of the device, resulting in the release of metal paricles within left hip joint. On (b)(6) 2019 patient received a revision surgery and the stem, modular neck and all other components were removed and replaced, the titanium modular neck had corroded and fatigued, and the dynasty liner having migrated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010536692-2020-00246 |
| MDR Report Key | 9844814 |
| Report Source | FOREIGN |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2019-03-07 |
| Date Facility Aware | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-17 |
| 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 | PROFEMUR? MODULAR FEMORAL NECK |
| Generic Name | HIP COMPONENT |
| Product Code | LWJ |
| Date Received | 2020-03-17 |
| Model Number | PHA01232 |
| Catalog Number | PHA01232 |
| Lot Number | 117485113 |
| 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 | 2020-03-17 |