MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2015-10-08 for G7 HI-WALL E1 LINER 36MM H N/A 010000938 manufactured by Biomet Orthopedics.
[27799885]
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. Device availability - 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
[27799886]
It was reported that patient underwent a total hip arthroplasty on (b)(6) 2015. During the procedure, the surgeon had trouble seating the liner in the cup, several attempts were made, this caused a delay greater than 30 minutes. Another liner was opened and used to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
[28829419]
Patient Sequence No: 1, Text Type: N, H10
[30048241]
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
[31394722]
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
[33381677]
Examination of returned device found no evidence of product non-conformance. Evaluation found some deformed areas where the liner is damaged. This damage likely occurred during the procedure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2015-04195 |
| MDR Report Key | 5134577 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-10-08 |
| Date of Report | 2015-12-08 |
| Date of Event | 2015-09-15 |
| Date Mfgr Received | 2015-12-08 |
| Device Manufacturer Date | 2015-02-13 |
| Date Added to Maude | 2015-10-08 |
| 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 HI-WALL E1 LINER 36MM H |
| Generic Name | PROSTHESIS, HIP |
| Product Code | LKD |
| Date Received | 2015-10-08 |
| Returned To Mfg | 2015-10-15 |
| Model Number | N/A |
| Catalog Number | 010000938 |
| Lot Number | 3517281 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | R |
| 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 | 2015-10-08 |