MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-04-04 for RINGLOC HI WALL TRIAL LINER SIZE 23 W/ 3/8 INCH SCREW N/A 33-108323 manufactured by Biomet Orthopedics.
[1894303]
It was reported that patient underwent hip arthroplasty on (b)(6) 2011. During the procedure as the surgeon was removing the trial liner, the locking clip and locking screw disassociated from the trial liner and fell into the patient's wound. Intraoperative radiographs were taken to aid in locating the components and the surgeon was able to retrieve them from the patient and complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
[8996936]
Review of device history records show that lot released with no recorded anomaly or deviation. Evaluation of the returned components found evidence to suggest that overtightening the device caused the event. 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 | 1825034-2011-00237 |
| MDR Report Key | 2037197 |
| Report Source | 07 |
| Date Received | 2011-04-04 |
| Date of Report | 2011-03-08 |
| Date of Event | 2011-02-25 |
| Date Facility Aware | 2011-04-01 |
| Date Mfgr Received | 2011-03-08 |
| Device Manufacturer Date | 2010-11-23 |
| Date Added to Maude | 2011-04-04 |
| 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 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 | RINGLOC HI WALL TRIAL LINER SIZE 23 W/ 3/8 INCH SCREW |
| Generic Name | DEVICE, PROSTHESIS ALIGNMENT |
| Product Code | IQO |
| Date Received | 2011-04-04 |
| Returned To Mfg | 2011-03-08 |
| Model Number | N/A |
| Catalog Number | 33-108323 |
| Lot Number | 105890 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 3 MO |
| 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 | 2011-04-04 |