MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-07-17 for COMPREHENSIVE INSTRUMENTATION HUMERAL TRIAL 44MM STANDARD - 36 MM STANDARD N/A 405940 manufactured by Biomet Orthopedics.
[2818631]
It was reported patient underwent a comprehensive reverse shoulder arthroplasty one month prior to revision. Subsequently, patient was revised on (b)(6), 2012 due to fracture and dislocation. During the procedure, instrument which seats the trial in place fractured.
Patient Sequence No: 1, Text Type: D, B5
[10046856]
The user facility is outside of the united states. No medwatch report was received. Current information is insufficient to permit a conclusion as to the cause of the event. The product identification necessary to review manufacturing history was not provided. There are warnings in the package insert that state that this type of event can occur: under precautions it states, "instruments that have experienced extensive use or excessive force are susceptible to fracture. Surgical instruments should only be used for their intended purpose. Biomet recommends that all instruments be regularly inspected for wear and disfigurement. " this report is number 4 of 4 mdrs filed for the same event (reference 1825034-2012-01049).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2012-01052 |
| MDR Report Key | 2657269 |
| Report Source | 01,07 |
| Date Received | 2012-07-17 |
| Date of Report | 2012-06-21 |
| Date of Event | 2012-06-21 |
| Date Mfgr Received | 2012-06-21 |
| Date Added to Maude | 2012-07-17 |
| 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 | 0 |
| Manufacturer Contact | MS. ANGELA DICKSON |
| Manufacturer Street | 56 EAST BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743711021 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 EAST 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 | COMPREHENSIVE INSTRUMENTATION HUMERAL TRIAL 44MM STANDARD - 36 MM STANDARD |
| Generic Name | TRIAL |
| Product Code | IQO |
| Date Received | 2012-07-17 |
| Model Number | N/A |
| Catalog Number | 405940 |
| Lot Number | N/A |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | N |
| 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 | 2012-07-17 |