MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-05-17 for HYBRID GLENOID TRIAL PS 4MM LARGE N/A 406194 manufactured by Biomet Orthopedics.
[1501473]
Patient underwent a shoulder procedure on (b) (6) 2010. The surgeon placed a trial glenoid inside the patient to gauge the size of glenoid implant required. Upon removal, one of the pegs from the glenoid trial was still in the prepared hole. Unintentionally, the peg was eventually pushed further into the prepared hole and lost behind the patient? S glenoid. The surgeon was unable to remove the peg, and as a result, the patient retained a foreign body.
Patient Sequence No: 1, Text Type: D, B5
[8657261]
Review of device history records show that lot released with no recorded anomaly or deviation. Evaluation of the returned component found some scratches and notches around the edge of the proximal rim. There were also scratches and gouges on the articulating surface and scratches on the perimeter edges. The fracture surface has ratchet marks along both side edges that suggest a fatigue fracture. (b) (4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825034-2010-00173 |
| MDR Report Key | 1691420 |
| Report Source | 07 |
| Date Received | 2010-05-17 |
| Date of Report | 2010-04-22 |
| Date of Event | 2010-04-22 |
| Date Facility Aware | 2010-05-04 |
| Date Mfgr Received | 2010-04-22 |
| Device Manufacturer Date | 2007-11-12 |
| Date Added to Maude | 2010-05-17 |
| 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 | 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 | HYBRID GLENOID TRIAL PS 4MM LARGE |
| Generic Name | PROSTHESIS, ALIGNMENT |
| Product Code | IQO |
| Date Received | 2010-05-17 |
| Returned To Mfg | 2010-04-23 |
| Model Number | N/A |
| Catalog Number | 406194 |
| Lot Number | 161900 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 2 YR |
| 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. Deathisabilit | 2010-05-17 |