MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-08-26 for G7 STR MONOBLOCK SHELL INSRTR N/A 110003450 manufactured by Biomet Orthopedics.
[24171079]
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 precautions states,? Intraoperative fracture or breaking of instruments has been reported for general instruments.? The device is reported to be available for evaluation; however, it has not been received by biomet orthopedics to date. In the event that the device is received and evaluated, a follow up report will be sent to the fda to provide results.
Patient Sequence No: 1, Text Type: N, H10
[24171080]
It was reported that during a total hip arthroplasty on (b)(6) 2015, the g7 inserter fractured off inside the cup. It was wedged in where it could not be removed from the cup. Another cup was used to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
[29510371]
This follow-up report is being filed to relay corrected information and additional information, which was unknown at the time of the initial medwatch. Examination of returned device found no evidence of product non-conformance. Product left conforming to print as there was no evidence that states otherwise. The acetabular inserter? S threads had fractured as stated in the complaint. Product likely failed due to misuse, as handles were designed to seat against the bottom of the threads in the cup. If the handle is not tightened down completely against this feature, damage to the threads of the handle is possible. The returned cup shows the fractured off threads that remain in the cup are not all the way threaded into the cup. The fracture pattern on the inserter? S threads also indicate that the surgeon levered the attached inserter handle while attempting to reposition the trial or definitive component which the inserter was not designed to do. Based on these results the complaint is considered confirmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2015-03838 |
| MDR Report Key | 5033197 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-08-26 |
| Date of Report | 2015-10-26 |
| Date of Event | 2015-07-27 |
| Date Mfgr Received | 2015-10-26 |
| Device Manufacturer Date | 2015-03-24 |
| Date Added to Maude | 2015-08-26 |
| 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 | 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 STR MONOBLOCK SHELL INSRTR |
| Generic Name | PROSTHESIS, HIP |
| Product Code | LKD |
| Date Received | 2015-08-26 |
| Returned To Mfg | 2015-09-04 |
| Model Number | N/A |
| Catalog Number | 110003450 |
| Lot Number | 415080 |
| 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 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-08-26 |