MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-03-07 for MONOBLOCK CUSTOM TRIAL HEAD 40MM N/A RD29143 manufactured by Biomet Orthopedics.
[1935245]
It was reported that patient underwent hip arthroplasty on (b)(6), 2011. As the surgeon performed trial reduction during the procedure, the trial head fractured. The fractured pieces were recovered and there was no injury to the patient or significant delay to the procedure as a result.
Patient Sequence No: 1, Text Type: D, B5
[9038834]
Review of device history records show that lot released with no recorded anomaly or deviation. No lot number is used with custom product. The head trial was received in three pieces. Evidence of fatigue fracture can be seen on all three of the components. The fatigue fracture appears to initiate at the undercut ring notch and propagate outward. Based on the information available at the time of this analysis, it appears that the monoblock head trial failed in fatigue with the fracture propagating from the undercut at the distal end of the taper radially to the outer diameter of the trial head. It appears that the taper channel fracture initiated from the undercut ring notch through to the outer diameter. This report submitted (b)(4), 2011.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 1825034-2011-00145 |
MDR Report Key | 2008733 |
Report Source | 07 |
Date Received | 2011-03-07 |
Date of Report | 2011-02-09 |
Date of Event | 2011-02-07 |
Date Facility Aware | 2011-03-01 |
Date Mfgr Received | 2011-02-09 |
Device Manufacturer Date | 2010-04-29 |
Date Added to Maude | 2011-03-07 |
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 | 3 |
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 | MONOBLOCK CUSTOM TRIAL HEAD 40MM |
Generic Name | DEVICE, PROSTHESIS ALIGNMENT |
Product Code | IQO |
Date Received | 2011-03-07 |
Returned To Mfg | 2011-02-11 |
Model Number | N/A |
Catalog Number | RD29143 |
ID Number | N/A |
Operator | PHYSICIAN |
Device Availability | R |
Device Age | 9 MO |
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 | 2011-03-07 |