MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-08-13 for RINGLOC HI-WALL TRIAL LINER 22X32MM N/A 31-108323 manufactured by Biomet Orthopedics.
[17893047]
It was reported that patient underwent hip arthroplasty on (b)(6) 2010. During the procedure, the spring washer of the trial acetabular liner came off and fell into the patient's wound. The surgeon was able to retrieve the washer from the patient and there was no significant delay to the procedure or injury to the patient as a result.
Patient Sequence No: 1, Text Type: D, B5
[17915768]
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. Manufacture date - unknown, the lot number identification needed to obtain information was not provided. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825034-2010-00334 |
| MDR Report Key | 1799776 |
| Report Source | 07 |
| Date Received | 2010-08-13 |
| Date of Report | 2010-07-21 |
| Date of Event | 2010-07-20 |
| Date Facility Aware | 2010-08-09 |
| Date Mfgr Received | 2010-07-21 |
| Date Added to Maude | 2010-08-13 |
| 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 | MRS. MIRANDA PARCELS |
| Manufacturer Street | 56 EAST BELL DRIVE P.O. BOX 587 |
| Manufacturer City | WARSAW IN 465810587 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810587 |
| Manufacturer Phone | 5742676639 |
| 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 22X32MM |
| Generic Name | DEVICE, PROSTHESIS ALIGNMENT |
| Product Code | IQO |
| Date Received | 2010-08-13 |
| Model Number | N/A |
| Catalog Number | 31-108323 |
| Lot Number | UNKNOWN |
| 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 EAST BELL DRIVE P.O. BOX 587 WARSAW IN 46581058 US 46581 0587 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-08-13 |