MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2020-02-04 for FLEXI ELBOW BUSH PAIR FEBSHA manufactured by Stanmore Implants Worldwide.
[177554153]
The reported device is similar to a device approved for compassionate use in the united states. An investigation is being performed in an attempt to identify the cause of the event. Should additional information become available it will be reported in a supplemental report. Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies. There have been no other similar events for the lot referenced. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[177554194]
I did this man? S 3rd revision elbow in 2013 and he has done well until recently following a fall. Looks like the bushings are worn out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004105610-2020-00021 |
| MDR Report Key | 9664181 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2020-02-04 |
| Date of Report | 2020-02-04 |
| Date of Event | 2020-01-10 |
| Date Mfgr Received | 2020-01-10 |
| Device Manufacturer Date | 2013-09-25 |
| Date Added to Maude | 2020-02-04 |
| 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 Contact | MRS. DIANA ROGERS |
| Manufacturer Street | 210 CENTENNIAL AVENUE CENTENNIAL PARK, ELSTREE |
| Manufacturer City | BOREHAMWOOD WD6 3SJ |
| Manufacturer Country | GB |
| Manufacturer Postal | WD6 3SJ |
| Manufacturer Phone | 2082386500 |
| Manufacturer G1 | STANMORE IMPLANTS WORLDWIDE |
| Manufacturer Street | 210 CENTENNIAL AVENUE CENTENNIAL PARK, ELSTREE |
| Manufacturer City | BOREHAMWOOD WD6 3SJ |
| Manufacturer Country | GB |
| Manufacturer Postal Code | WD6 3SJ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXI ELBOW BUSH PAIR |
| Generic Name | PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED |
| Product Code | JDC |
| Date Received | 2020-02-04 |
| Catalog Number | FEBSHA |
| Lot Number | B12112 |
| Device Expiration Date | 2018-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STANMORE IMPLANTS WORLDWIDE |
| Manufacturer Address | 210 CENTENNIAL AVENUE CENTENNIAL PARK, ELSTREE BOREHAMWOOD WD6 3SJ GB WD6 3SJ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-02-04 |