MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-10-02 for COMPREHENSIVE GLENOID BASEPLATE TRIAL N/A 405902 manufactured by Biomet Orthopedics.
[1176041]
It was reported that patient underwent a reverse shoulder procedure utilizing a glenoid baseplate trial in 2009. During the procedure, the surgeon had difficulty fitting the baseplate trial over the steinman pin. The steinman pin advanced too far and punctured the patient? S lung. Patient was reported to have a chest tube as a result. No further information has been reported to date.
Patient Sequence No: 1, Text Type: D, B5
[1251369]
It was reported that patient underwent a reverse shoulder procedure utilizing a glenoid baseplate trial in 2009. During the procedure, the surgeon had difficulty fitting the baseplate trial over the steinman pin and the pin advanced further due to the patient's extremely soft bone. Additional information provided by the user facility stated that it would have been impossible for the pin to advance far enough to cause the puncture to the patient's lung.
Patient Sequence No: 1, Text Type: D, B5
[8333858]
A change was initiated in 2009, to expand through hole diameter. There were no other units outstanding as all units were within biomet control. This report filed november 24, 2009.
Patient Sequence No: 1, Text Type: N, H10
[8415486]
User facility filed report after receiving a faxed letter from biomet on september 23, 2009 with event details. This follow-up report is being filed to make the fda aware that both the manufacturer report number and user facility report number referenced in this medwatch are for the same patient, part number and event. This report filed october 14, 2009.
Patient Sequence No: 1, Text Type: N, H10
[20347515]
It was reported that patient underwent a reverse shoulder procedure utilizing a glenoid baseplate trial in 2009. During the procedure, the surgeon had difficulty fitting the baseplate trial over the steinman pin. The steinman pin advanced too far and as a result, the patient? S lung was punctured. Patient was reported to have a chest tube as a result. No further information has been reported to date.
Patient Sequence No: 1, Text Type: D, B5
[20397881]
Review of device history records show that lot released with no recorded anomaly or deviation. Dimensional evaluation found component to be within appropriate design specification. Evaluation of the returned component confirmed the problem reported that the glenoid baseplate trial would not fit over the steinman pin. This report filed october 2, 2009.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825034-2009-00224 |
| MDR Report Key | 1489686 |
| Report Source | 07 |
| Date Received | 2009-10-02 |
| Date of Report | 2009-09-04 |
| Date of Event | 2009-08-26 |
| Date Facility Aware | 2009-09-23 |
| Date Mfgr Received | 2009-09-04 |
| Device Manufacturer Date | 2009-04-23 |
| Date Added to Maude | 2009-11-24 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | MRS. MIRANDA PARCELS |
| Manufacturer Street | 56 EAST BELL DRIVE P.O. BOX 587 |
| Manufacturer City | WARSAW IN 465810587 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810587 |
| Manufacturer Phone | 5742676639 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 EAST BELL DRIVE P.O. BOX 587 |
| Manufacturer City | WARSAW IN 46581058 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46581 0587 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPREHENSIVE GLENOID BASEPLATE TRIAL |
| Generic Name | DEVICE, PROSTHESIS ALIGNMENT |
| Product Code | IQO |
| Date Received | 2009-10-02 |
| Returned To Mfg | 2009-09-04 |
| Model Number | N/A |
| Catalog Number | 405902 |
| Lot Number | 236620 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 EAST BELL DRIVE P.O. BOX 587 WARSAW IN 46581058 US 46581 0587 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2009-10-02 |