MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-11-08 for SNAP-ON TRIAL HEAD -6 ALIGNMENT 36MM SIZE N/A RDW03083 manufactured by Biomet Orthopedics.
[2224802]
It was reported that patient underwent total hip arthroplasty on (b)(6) 2011. Subsequently, the surgeon was trialing the modular head when it fractured into multiple pieces. The procedure was completed using another set of head trials that were on hand.
Patient Sequence No: 1, Text Type: D, B5
[9389910]
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. The user facility was notified of the event on (b)(6) 2011. In the event that the user facility submits a medwatch report, biomet will forward a copy to the fda. Evaluation of returned device indicates that the modular head trial fractured due to a brittle fracture.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2011-00977 |
| MDR Report Key | 2328408 |
| Report Source | 07 |
| Date Received | 2011-11-08 |
| Date of Report | 2011-10-13 |
| Date of Event | 2011-09-27 |
| Date Mfgr Received | 2011-10-13 |
| Device Manufacturer Date | 2011-01-17 |
| Date Added to Maude | 2011-11-09 |
| 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 | MR. CRAIG BUCHMAN |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| Manufacturer Phone | 5743711132 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46581 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SNAP-ON TRIAL HEAD -6 ALIGNMENT 36MM SIZE |
| Generic Name | DEVICE, PROSTHESIS ALIGNMENT |
| Product Code | IQO |
| Date Received | 2011-11-08 |
| Returned To Mfg | 2011-10-13 |
| Model Number | N/A |
| Catalog Number | RDW03083 |
| Lot Number | UNK |
| 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 46581 US 46581 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2011-11-08 |