MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2011-07-26 for PROVISIONAL MODULAR HEAD 32MM PLUS 3MM NECK N/A 31-473535 manufactured by Biomet Orthopedics.
[2140164]
It was reported that patient underwent hip procedure on unknown date. As the surgeon was completing final trialing for neck length of the stem, the femoral head trial became dislodged and migrated to behind the psoas muscle. During attempted retrieval, the trial head fell over the brim of the pelvis. The surgeon attempted to retrieve the trial head multiple times, but was unsuccessful. The trial liner was retained by the patient and there was a significant delay to the procedure as the surgeon attempted to locate and remove the trial head.
Patient Sequence No: 1, Text Type: D, B5
[9251448]
The lot number information needed to review device history records was unavailable. Date of event - date of event is unknown. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825034-2011-00622 |
| MDR Report Key | 2176582 |
| Report Source | 00 |
| Date Received | 2011-07-26 |
| Date of Report | 2011-06-27 |
| Date Mfgr Received | 2011-06-27 |
| Date Added to Maude | 2011-07-26 |
| 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 | MR. CRAIG BUCHMAN |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| Manufacturer Phone | 5743711132 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 E. BELL DRIVE |
| 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 | PROVISIONAL MODULAR HEAD 32MM PLUS 3MM NECK |
| Generic Name | DEVICE, PROSTHESIS ALIGNMENT |
| Product Code | IQO |
| Date Received | 2011-07-26 |
| Model Number | N/A |
| Catalog Number | 31-473535 |
| Lot Number | UNKNOWN |
| 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 46581058 US 46581 0587 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2011-07-26 |