MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-04-14 for ULTRA-DRIVE III CONSOLE N/A 423935 manufactured by Biomet Orthopedics.
[42672403]
The product identification necessary to review manufacturing history was not provided. Current information is insufficient to permit a conclusion as to the cause of the event. There are warnings in the package insert that state that this type of event can occur: under warnings, number 1 states, "the ultra-drive? System is to be operated in accordance to the operator? S manual. " product location unknown.
Patient Sequence No: 1, Text Type: N, H10
[42672404]
It was reported a patient underwent an initial total hip arthroplasty and partial femoral replacement procedure on (b)(6) 2015. Subsequently, the patient experienced multiple dislocations and was revised on (b)(6) 2015. The patient was further revised on (b)(6) 2016 due to dislocation. It was reported the patient had poor bone and ligament quality. The patient also had no adductor muscles which likely contributed to the dislocations. During the (b)(6) 2016 revision procedure, the cement removal console would not function and showed error messages. This resulted in approximately a 40 minute delay in the procedure, as flexible osteotomes, a mallet, curettes and nippers had to be utilized to complete the procedure. The sales representative reported that the console was mishandled.
Patient Sequence No: 1, Text Type: D, B5
[44478196]
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. During the evaluation, the instrument showed evidence of processor failure and fractured pieces within device. The instrument was repaired and functionality was restored. Root cause of the event was most likely attributed to the instrument being mishandled.
Patient Sequence No: 1, Text Type: N, H10
[45540714]
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2016-01285 |
| MDR Report Key | 5577321 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-04-14 |
| Date of Report | 2016-04-22 |
| Date of Event | 2016-02-27 |
| Date Mfgr Received | 2016-04-22 |
| Date Added to Maude | 2016-04-14 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MEGAN HAAS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743726700 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRA-DRIVE III CONSOLE |
| Generic Name | DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT |
| Product Code | JXE |
| Date Received | 2016-04-14 |
| Model Number | N/A |
| Catalog Number | 423935 |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| 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 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2016-04-14 |