MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-09-12 for ARCOS MODULAR REVISION SYSTEM CONE BODY TRIAL SIZE D 70MM HIGH OFFSET N/A 31-301334 manufactured by Biomet Orthopedics.
[9562422]
Supplier reviewed manufacturing history and determined the order was mixed at the anodize vendor. All possible units that may have been affected were found to be conforming with the exception of one additional unit, which was identified as being the mixed part. The investigation determined the event was isolated to these two units. Both units identified as being non-conforming are within biomet control. This report filed (b)(4), 2011.
Patient Sequence No: 1, Text Type: N, H10
[16420663]
Investigation into the issue is ongoing. Evaluation of an additional unit from this lot found it to be conforming. A review of complaint history confirmed no other complaints for this lot. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[16534101]
It was reported that patient underwent hip arthroplasty procedure utilizing a cone trial on (b)(6) 2011. It was discovered that the device was marked as high-offset and was the color of a high-offset trial cone, but it was not a high-offset. The surgeon trialed for a standard size implant and did not need a high offset trial to complete the procedure. There was no injury to the patient or delay to the procedure as a result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825034-2011-00804 |
| MDR Report Key | 2243337 |
| Report Source | 07 |
| Date Received | 2011-09-12 |
| Date of Report | 2011-08-18 |
| Date of Event | 2011-08-17 |
| Date Mfgr Received | 2011-08-18 |
| Device Manufacturer Date | 2011-02-17 |
| Date Added to Maude | 2011-10-26 |
| 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 | ARCOS MODULAR REVISION SYSTEM CONE BODY TRIAL SIZE D 70MM HIGH OFFSET |
| Generic Name | PROSTHESIS ALIGNMENT DEVICE |
| Product Code | IQO |
| Date Received | 2011-09-12 |
| Returned To Mfg | 2011-08-22 |
| Model Number | N/A |
| Catalog Number | 31-301334 |
| Lot Number | 427180 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| 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 | 2011-09-12 |