MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-11 for G7 STR MODULAR SHELL INSERTER N/A 110003451 manufactured by Biomet Orthopedics.
[26075905]
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. This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015-03949).
Patient Sequence No: 1, Text Type: N, H10
[26075906]
It was reported that a patient underwent an initial hip arthroplasty on (b)(6) 2015. During the procedure, the cup inserter became marred upon impaction and the inner lock bolt became captured inside the handle. The entry hole was also disfigured and the inner bolt could not pass freely. The distal thread also became deformed due to impaction. The inner poly was seated by impaction. The inserter was used to complete the procedure. No further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
[28844596]
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
[31696170]
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. Examination of returned device found no evidence of product non-conformance. Based on device history records, the product was made to print and correct materials. He threaded inserter shaft cannot be inserted into the through hole of the handle body due to the damage. Instrument likely failed due to excessive impacts to the strike plate, which deformed material around through hole.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2015-03948 |
| MDR Report Key | 5070259 |
| Date Received | 2015-09-11 |
| Date of Report | 2015-11-18 |
| Date of Event | 2015-08-19 |
| Date Mfgr Received | 2015-11-18 |
| Device Manufacturer Date | 2015-01-19 |
| Date Added to Maude | 2015-09-11 |
| 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 MODULAR SHELL INSERTER |
| Generic Name | PROSTHESIS, HIP |
| Product Code | LKD |
| Date Received | 2015-09-11 |
| Returned To Mfg | 2015-09-30 |
| Model Number | N/A |
| Catalog Number | 110003451 |
| Lot Number | 998290 |
| 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 | 2015-09-11 |