MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-10-10 for MODULAR HEAD THREADED NECK TRIAL N/A 31-482592 manufactured by Biomet Orthopedics.
[2282773]
It was reported that patient underwent total hip arthroplasty procedure utilizing a modular head threaded neck trial on (b)(6) 2011. During the procedure, as the surgeon was attempting head reduction, the neck trial fractured. The surgeon retrieved the fractured pieces from the patient's wound and the surgery was completed without significant delay.
Patient Sequence No: 1, Text Type: D, B5
[9354875]
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. Evaluation of the returned device confirmed it was fractured nearly in half on the tapered end. The angled fracture suggests a torsional load. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825034-2011-00895 |
| MDR Report Key | 2284008 |
| Report Source | 07 |
| Date Received | 2011-10-10 |
| Date of Report | 2011-09-15 |
| Date of Event | 2011-09-14 |
| Date Mfgr Received | 2011-09-15 |
| Device Manufacturer Date | 2010-11-22 |
| Date Added to Maude | 2011-10-11 |
| 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 EAST BELL DRIVE P.O. BOX 587 |
| Manufacturer City | WARSAW IN 465810587 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810587 |
| Manufacturer Phone | 5743711132 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 EAST BELL DRIVE P.O. BOX 587 |
| 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 | MODULAR HEAD THREADED NECK TRIAL |
| Generic Name | PROSTHESIS ALIGNMENT DEVICE |
| Product Code | IQO |
| Date Received | 2011-10-10 |
| Returned To Mfg | 2011-09-15 |
| Model Number | N/A |
| Catalog Number | 31-482592 |
| Lot Number | ZB108003 |
| 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 EAST BELL DRIVE P.O. BOX 587 WARSAW IN 46581058 US 46581 0587 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2011-10-10 |