MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-06-10 for HIP FRACTURE STEM BROACH/PROVISIONAL N/A 31-473903 manufactured by Biomet Orthopedics.
[2021572]
It was reported that patient underwent hip procedure on (b)(6) 2011. During the procedure, the surgeon reamed and broached up to 14mm. However, the 14mm stem sat about 5mm proud. The surgeon repeated reaming and broaching several more times. The 14mm stem toggled in the femoral canal, but still sat proud. The procedure was completed implanting a cemented 12mm stem that was on hand with no delay to the procedure or injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
[8984778]
The returned component is very worn from being used beyond the recommended lifetime of the device. The user facility was notified of the event on (b)(6) 2011. To date, a response has not been received from the user facility. In the event that the user facility submits a medwatch report, biomet will forward a copy to the fda. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825034-2011-00496 |
| MDR Report Key | 2120591 |
| Report Source | 07 |
| Date Received | 2011-06-10 |
| Date of Report | 2011-05-14 |
| Date of Event | 2011-04-28 |
| Date Mfgr Received | 2011-05-14 |
| Device Manufacturer Date | 1998-03-20 |
| Date Added to Maude | 2011-08-25 |
| 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 46581058 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46581 0587 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HIP FRACTURE STEM BROACH/PROVISIONAL |
| Generic Name | DEVICE, PROSTHESIS ALIGNMENT |
| Product Code | IQO |
| Date Received | 2011-06-10 |
| Returned To Mfg | 2011-05-14 |
| Model Number | N/A |
| Catalog Number | 31-473903 |
| Lot Number | 309500 |
| 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 46581058 US 46581 0587 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-10 |