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 3/8" SCREW SIZE 25X36MM ID N/A 33-115845 manufactured by Biomet Orthopedics.
[2057654]
It was reported that patient underwent hip arthroplasty procedure utilizing a trial acetabular liner on (b)(6) 2011. During the procedure, the surgeon removed the trial liner after trial reduction and noted the clip and screw had disassembled from it. The surgeon noted also that the dome of the liner had fractured. The procedure was completed without injury to the patient or retention of a foreign body. There was no significant delay to the procedure as a result.
Patient Sequence No: 1, Text Type: D, B5
[9128245]
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 and clip are missing and the flange is deformed. It appears the screw pulled out through the dome flange under a torsional load. 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 | 1825034-2011-00498 |
| MDR Report Key | 2120515 |
| Report Source | 07 |
| Date Received | 2011-06-10 |
| Date of Report | 2011-05-16 |
| Date of Event | 2011-03-28 |
| Date Mfgr Received | 2011-05-16 |
| Device Manufacturer Date | 2010-06-15 |
| Date Added to Maude | 2011-08-25 |
| 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 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 + MAXROM TRIAL LINER 3/8" SCREW SIZE 25X36MM ID |
| Generic Name | DEVICE, PROSTHESIS ALIGNMENT |
| Product Code | IQO |
| Date Received | 2011-06-10 |
| Returned To Mfg | 2011-05-16 |
| Model Number | N/A |
| Catalog Number | 33-115845 |
| Lot Number | 21443154 |
| 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 EAST BELL DRIVE P.O. BOX 587 WARSAW IN 46581058 US 46581 0587 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-10 |