MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-09-09 for RINGLOC + HI-WALL TRIAL LINER 3/8" SCREW SIZE 25 X 44MM I.D. N/A 33-108725 manufactured by Biomet Orthopedics.
[2322267]
It was reported that patient underwent hip revision procedure on (b)(6) 2011. During trialing, the surgeon noticed that the screw had fractured from the trial liner. The trial liner and screw were removed from the surgical site. The procedure was completed with no injury to the patient or delay to the procedure.
Patient Sequence No: 1, Text Type: D, B5
[9288040]
Review of device history records show that lot released with no recorded anomaly or deviation. Evaluation of returned device found evidence that suggests the screw was over-torqued into the cup. The user facility was notified of the event on (b)(4) 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 | 1825034-2011-00800 |
| MDR Report Key | 2241527 |
| Report Source | 07 |
| Date Received | 2011-09-09 |
| Date of Report | 2011-08-16 |
| Date of Event | 2011-08-15 |
| Date Mfgr Received | 2011-08-16 |
| Device Manufacturer Date | 2010-09-18 |
| Date Added to Maude | 2011-10-06 |
| 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 | RINGLOC + HI-WALL TRIAL LINER 3/8" SCREW SIZE 25 X 44MM I.D. |
| Generic Name | DEVICE, PROSTHESIS ALIGNMENT |
| Product Code | IQO |
| Date Received | 2011-09-09 |
| Returned To Mfg | 2011-08-17 |
| Model Number | N/A |
| Catalog Number | 33-108725 |
| Lot Number | 484703 |
| 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 | 2011-09-09 |