MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study report with the FDA on 2015-09-24 for G7 NEUTRAL E1 LINER 32MM C N/A 010000847 manufactured by Biomet Orthopedics.
[26720368]
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 possible adverse effects, number 2 states,? Early or late postoperative infection and allergic reaction.? Number 8 states, "dislocation and subluxation due to inadequate fixation, malalignment, malposition, excessive, unusual and/or awkward movement and/or activity, trauma, weight gain, or obesity. " this report is number 2 of 2 mdrs filed for the same event (reference 1825034-2014-07690).
Patient Sequence No: 1, Text Type: N, H10
[26720369]
It was reported a patient enrolled in a clinical study underwent total left hip arthroplasty on (b)(6) 2014. Subsequently, the patient experienced dislocation and a superficial infection; however, no revision procedure has been reported to date.
Patient Sequence No: 1, Text Type: D, B5
[28837926]
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
[55801766]
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. 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. There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 2 states,? Early or late postoperative infection and allergic reaction.? Number 8 states, "dislocation and subluxation due to inadequate fixation, malalignment, malposition, excessive, unusual and/or awkward movement and/or activity, trauma, weight gain, or obesity. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2015-04058 |
| MDR Report Key | 5102895 |
| Report Source | STUDY |
| Date Received | 2015-09-24 |
| Date of Report | 2016-08-28 |
| Date Mfgr Received | 2016-08-28 |
| Device Manufacturer Date | 2013-08-20 |
| Date Added to Maude | 2015-09-24 |
| 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 32MM C |
| Generic Name | PROSTHESIS, HIP |
| Product Code | LKD |
| Date Received | 2015-09-24 |
| Model Number | N/A |
| Catalog Number | 010000847 |
| Lot Number | 3117782 |
| ID Number | N/A |
| Device Expiration Date | 2018-08-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Required No Informationntervention | 2015-09-24 |