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 2020-03-25 for EXTENDIBLE TOTAL HUMERAL REPLACEMENT - MINIMALLY INVASIVE GROWER UNK_STM manufactured by Stanmore Implants Worldwide.
[188058851]
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. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[188058852]
A patient specific prescription form was received reporting the following: left side. Reason for revision: luxation and instability. Device being requested is a total bayley walker shoulder. Proposed date of surgery is blank. Other notes are "bw type. Flexy elbow. Elbow stem 50mm. Overall replacement - 10mm shorter than current replacement (with extension). "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004105610-2020-00071 |
| MDR Report Key | 9877371 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2018-06-11 |
| Date Added to Maude | 2020-03-25 |
| 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 | MR. COLLIN NEITZEL |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| 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 | EXTENDIBLE TOTAL HUMERAL REPLACEMENT - MINIMALLY INVASIVE GROWER |
| Generic Name | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED |
| Product Code | KWS |
| Date Received | 2020-03-25 |
| Catalog Number | UNK_STM |
| Lot Number | PIN 21343 |
| 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. Other | 2020-03-25 |