MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2015-03-19 for ASCEND HUMERAL STEM SIZE 4A; 78MM 127.5 503304A manufactured by .
[19316084]
Subluxation anterior; subluxation of prosthesis anteriorly on the axillary view with superior humeral migration on the static and dynamic resulting in revision to reverse shoulder arthroplasty on (b)(6) 2014.
Patient Sequence No: 1, Text Type: D, B5
[19706036]
This is the initial report submitted regarding this surgical event and medical device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004983210-2015-00008 |
| MDR Report Key | 4628090 |
| Report Source | 99 |
| Date Received | 2015-03-19 |
| Date of Report | 2015-02-24 |
| Date of Event | 2014-08-27 |
| Date Added to Maude | 2015-05-07 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KEVIN SMITH |
| Manufacturer Street | 10801 NESBITT AVE S |
| Manufacturer City | BLOOMINGTON MN 55437 |
| Manufacturer Country | US |
| Manufacturer Postal | 55437 |
| Manufacturer Phone | 9529217121 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASCEND HUMERAL STEM SIZE 4A; 78MM 127.5 |
| Generic Name | NONE |
| Product Code | KWH |
| Date Received | 2015-03-19 |
| Catalog Number | 503304A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-19 |