MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-05-10 for RINGLOC HI WALL TRIAL LINER N/A 33-108725 manufactured by Biomet Orthopedics.
[2022272]
It was reported that patient underwent hip revision procedure on (b)(6) 2011. During the procedure, after trialing, the surgeon noted that the trial liner had separated from the screw portion of the liner. The surgeon unscrewed the screw from the bottom of the cup. A standard liner was used to complete the procedure. No injury to the patient or delay in the procedure was reported.
Patient Sequence No: 1, Text Type: D, B5
[9109768]
Current information is insufficient to permit a conclusion as to the cause of the event. The lot number information needed to review device history records was unavailable. 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 | 1825034-2011-00368 |
| MDR Report Key | 2083057 |
| Report Source | 07 |
| Date Received | 2011-05-10 |
| Date of Report | 2011-04-14 |
| Date of Event | 2011-03-03 |
| Date Facility Aware | 2011-05-09 |
| Date Mfgr Received | 2011-04-14 |
| Date Added to Maude | 2011-05-19 |
| 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 HI WALL TRIAL LINER |
| Generic Name | DEVICE, PROSTHESIS ALIGNMENT |
| Product Code | IQO |
| Date Received | 2011-05-10 |
| Model Number | N/A |
| Catalog Number | 33-108725 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2011-05-10 |