MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-10-27 for G7 NEUTRAL E1 LINER 36MM E N/A 010000857 manufactured by Biomet Orthopedics.
[29382101]
Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show that lot released with no recorded anomaly or deviation. Evaluation in process but not yet complete. Upon completion of evaluation, a follow up report will be sent to the fda. There are warnings in the package insert that state that this type of event can occur: under warnings, it states,? Improper selection, placement, positioning, alignment and/or fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components.?
Patient Sequence No: 1, Text Type: N, H10
[29382102]
It was reported that patient underwent a total hip arthroplasty on (b)(6), 2015. During the procedure, the liner was not seating. The surgeon attempted to seat for 20-25 minutes and was unsuccessful. A second liner was impacted; however, the cup had moved position and the surgeon was not satisfied. Another shell and liner were implanted to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2015-04427 |
| MDR Report Key | 5181002 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-10-27 |
| Date of Report | 2015-09-30 |
| Date of Event | 2015-09-30 |
| Date Mfgr Received | 2015-09-30 |
| Device Manufacturer Date | 2015-02-03 |
| Date Added to Maude | 2015-10-27 |
| 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 | G7 NEUTRAL E1 LINER 36MM E |
| Generic Name | PROSTHESIS, HIP |
| Product Code | LKD |
| Date Received | 2015-10-27 |
| Returned To Mfg | 2015-10-08 |
| Model Number | N/A |
| Catalog Number | 010000857 |
| Lot Number | 3508141 |
| 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 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2015-10-27 |