MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-23 for FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 S PHA04402 manufactured by Microport Orthopedics Inc..
[184652516]
This event will be updated once the investigation is complete. Trends will be evaluated.
Patient Sequence No: 1, Text Type: N, H10
[184652517]
Allegedly, patient was revised due to dislocation. Mpo procotyl implants removed and replaced with mpo dynasty implants. 28mm femoral head removed and changed to 32mm femoral head. The surgeon believes that an error in relocating the hip caused the cup to move. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010536692-2020-00261 |
| MDR Report Key | 9868205 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date Facility Aware | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-23 |
| 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 | FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 S |
| Generic Name | HIP COMPONENT |
| Product Code | LZO |
| Date Received | 2020-03-23 |
| Model Number | PHA04402 |
| Catalog Number | PHA04402 |
| Lot Number | 1826426 |
| 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 | 2020-03-23 |