MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-03-02 for RINGLOC HI-WALL & TRIAL LINER SIZE 24 X 40MM I.D. N/A 31-108524 manufactured by Biomet Orthopedics.
[1718099]
It was reported that patient underwent hip procedure on (b)(6) 2011. During the procedure, the trial insert clip disassociated and radiographs revealed that it was retained between the bearing and acetabular cup. The insert clip was removed with no injury to the patient and no delay in the procedure.
Patient Sequence No: 1, Text Type: D, B5
[9096417]
Device manufacture date - unknown. The lot number information needed to review device history records was unavailable. Other - two trial liners of size 24 and size 27 were returned. One clip was too deformed for an accurate dimensional analysis but the other was within tolerance. The screws from both liners were within tolerance. It could not be determined if either liner was the unit referenced in this complaint. 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 | 1825034-2011-00135 |
| MDR Report Key | 2004861 |
| Report Source | 07 |
| Date Received | 2011-03-02 |
| Date of Report | 2011-02-03 |
| Date of Event | 2011-01-03 |
| Date Facility Aware | 2011-02-28 |
| Date Mfgr Received | 2011-02-03 |
| Date Added to Maude | 2011-03-04 |
| 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 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 SIZE 24 X 40MM I.D. |
| Generic Name | DEVICE, PROSTHESIS ALIGNMENT |
| Product Code | IQO |
| Date Received | 2011-03-02 |
| Model Number | N/A |
| Catalog Number | 31-108524 |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | Y |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2011-03-02 |