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 RINGLOC + MAXROM TRIAL LINER SIZE 24 X 32 MM I.D. N/A 33-115834 manufactured by Biomet Orthopedics.
[2017557]
It was reported that patient underwent hip procedure on (b)(6), 2011. Upon removal of the trial liner following a trial reduction, surgeon discovered that the screw and clip had disassociated. Surgeon also discovered that the trial liner was fracturing. The surgery was completed with no injury to the patient or delay in the procedure. No foreign bodies were retained.
Patient Sequence No: 1, Text Type: D, B5
[8986670]
Review of receiving certificate of conformance showed that lot had no anomaly or deviation. The trial has scratches, gouges, and wear marks on most surfaces. The screw head has scratches on it. There are dome cracks around the flange and some of the polymer appears missing around the edge of the hole. The cracks around the dome flange could have been caused by the cumulative stresses of impact and temperature cycling during autoclaving. 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. This report submitted (b)(4), 2011.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825034-2011-00484 |
| MDR Report Key | 2120487 |
| Report Source | 07 |
| Date Received | 2011-06-10 |
| Date of Report | 2011-05-16 |
| Date of Event | 2011-05-10 |
| Date Facility Aware | 2011-06-09 |
| Date Mfgr Received | 2011-05-16 |
| Device Manufacturer Date | 2010-04-30 |
| Date Added to Maude | 2011-06-10 |
| 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 | RINGLOC + MAXROM TRIAL LINER SIZE 24 X 32 MM I.D. |
| Generic Name | DEVICE, PROSTHESIS ALIGNMENT |
| Product Code | IQO |
| Date Received | 2011-06-10 |
| Returned To Mfg | 2011-05-18 |
| Model Number | N/A |
| Catalog Number | 33-115834 |
| Lot Number | 21443132 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 1 YR |
| 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 |