MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-12-22 for PROFEMUR(R) STEM RASP APA0-1070 manufactured by Microport Orthopedics Inc..
[63107974]
This complaint will be updated once investigation is complete. Trends will be evaluated.
Patient Sequence No: 1, Text Type: N, H10
[63107975]
Allegedly, distal tip broke off starter broach in patient femur.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010536692-2016-01546 |
| MDR Report Key | 6198878 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-12-22 |
| Date of Report | 2016-12-21 |
| Date of Event | 2016-12-19 |
| Date Facility Aware | 2016-12-21 |
| Date Mfgr Received | 2016-12-21 |
| Date Added to Maude | 2016-12-22 |
| 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(R) STEM RASP |
| Generic Name | HIP INSTRUMENT |
| Product Code | GAC |
| Date Received | 2016-12-22 |
| Catalog Number | APA0-1070 |
| Lot Number | NI |
| Device Availability | N |
| Device Age | DA |
| 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 | 2016-12-22 |