MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-04-03 for COMPREHENSIVE INSTRUMENTION HUMERAL TRIAL 44MM STANDARD - 36MM STANDARD N/A 405940 manufactured by Biomet Orthopedics.
[18498149]
It was reported that patient underwent reverse shoulder arthroplasty on (b)(6), 2012. During the final trial reduction phase, the post fractured off the trial bearing, and had to be the removed from the patient. The procedure was completed with no significant delay to the procedure, and no foreign bodies were retained by the patient.
Patient Sequence No: 1, Text Type: D, B5
[18677656]
The physical condition of the trial suggests interaction with a sharp surgical instrument and the fracture of the device was caused by bending overload. Review of device history records show that lot released with no recorded anomaly or deviation. The user facility was notified of the event on (b)(6), 2012. In the event that the user facility submits a medwatch report, biomet will forward a copy to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2012-00360 |
| MDR Report Key | 2514231 |
| Report Source | 07 |
| Date Received | 2012-04-03 |
| Date of Report | 2012-03-05 |
| Date of Event | 2012-03-05 |
| Date Mfgr Received | 2012-03-05 |
| Device Manufacturer Date | 2010-02-09 |
| Date Added to Maude | 2012-04-03 |
| 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 INSTRUMENTION HUMERAL TRIAL 44MM STANDARD - 36MM STANDARD |
| Generic Name | DEVICE, PROSTHESIS ALIGNMENT |
| Product Code | IQO |
| Date Received | 2012-04-03 |
| Returned To Mfg | 2012-03-08 |
| Model Number | N/A |
| Catalog Number | 405940 |
| Lot Number | 477810 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | R |
| 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 | 2012-04-03 |