MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-06-06 for COMPREHENSIVE REVERSE HUMERAL TI TRAY 44MM N/A 115340 manufactured by Biomet Orthopedics.
[2784465]
It was reported that patient underwent reverse shoulder arthroplasty on (b)(6) 2009. Subsequently, patient was revised on (b)(6) 2012, due to fracture of the trunnion on the humeral tray component.
Patient Sequence No: 1, Text Type: D, B5
[9827842]
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. There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number ten states, "fatigue fracture of component can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, or excessive weight". Evaluation in process but not yet complete. Upon completion of evaluation, a follow up report will be sent to the fda.
Patient Sequence No: 1, Text Type: N, H10
[17400737]
The tibial bearing and plate were returned still assembled. Any effort to separate the two components would result in destruction of the bearing component; therefore no attempt was made to separate the two components. No evaluation could be performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2012-00802 |
| MDR Report Key | 2600648 |
| Report Source | 07 |
| Date Received | 2012-06-06 |
| Date of Report | 2012-05-09 |
| Date of Event | 2012-05-10 |
| Date Mfgr Received | 2012-05-09 |
| Device Manufacturer Date | 2009-10-26 |
| Date Added to Maude | 2012-06-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. ANGELA DICKSON |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743711021 |
| 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 | 3 |
| Brand Name | COMPREHENSIVE REVERSE HUMERAL TI TRAY 44MM |
| Generic Name | PROSTHESIS, SHOULDER |
| Product Code | BSN |
| Date Received | 2012-06-06 |
| Returned To Mfg | 2012-05-22 |
| Model Number | N/A |
| Catalog Number | 115340 |
| Lot Number | 607420 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2012-06-06 |