MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-04 for COMP RVS HMRLTRL 44STD-36STD N/A 405940 manufactured by Biomet Orthopedics.
[37675015]
Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show that lot released with no recorded anomaly or deviation.
Patient Sequence No: 1, Text Type: N, H10
[37675016]
It was reported that during an initial reverse shoulder arthroplasty on (b)(6) 2016, the post on the humeral tray trial fractured off into the trial stem. The fractured piece was removed and the procedure was completed without delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2016-00362 |
| MDR Report Key | 5410274 |
| Date Received | 2016-02-04 |
| Date of Report | 2016-01-12 |
| Date of Event | 2016-01-11 |
| Date Mfgr Received | 2016-01-12 |
| Device Manufacturer Date | 2015-05-27 |
| Date Added to Maude | 2016-02-04 |
| 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 | MS. MEGAN HAAS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743726700 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COMP RVS HMRLTRL 44STD-36STD |
| Generic Name | DEVICE, PROSTHESIS ALIGNMENT |
| Product Code | IQO |
| Date Received | 2016-02-04 |
| Model Number | N/A |
| Catalog Number | 405940 |
| Lot Number | ZB150401 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-04 |