MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-01-12 for UNKNOWN N/A manufactured by Biomet France S.a.r.l..
[35694609]
This user facility is outside of the united states. The product identification necessary to review manufacturing history was not provided. Current information is insufficient to permit a conclusion as to the cause of the event. Event is being reported to fda on one medwatch since the limited information available indicates that a revision procedure occurred. Should additional information be received regarding the revision procedure, the complaint will be reassessed and, if warranted, further medwatch reports will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[35694610]
It was reported that patient underwent an unknown procedure on an unknown date. Subsequently, a revision procedure was performed on an unknown date due to unknown reasons. During the procedure, the monomer did not enter the cylinder. However, there was no patient injury and no delay in procedure. No further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006946279-2016-00001 |
| MDR Report Key | 5360967 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-01-12 |
| Date of Report | 2015-12-18 |
| Date Mfgr Received | 2015-12-18 |
| Date Added to Maude | 2016-01-12 |
| 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 | MR. CHRISTOPHE MIRONNEAU |
| Manufacturer Street | PLATEAU DE LAUTAGNE BP75 |
| Manufacturer City | VALENCE CEDEX 26903 |
| Manufacturer Country | FR |
| Manufacturer Postal | 26903 |
| Manufacturer Phone | 0334757591 |
| Manufacturer G1 | BIOMET FRANCE S.A.R.L. |
| Manufacturer Street | PLATEAU DE LAUTAGNE BP75 |
| Manufacturer City | VALENCE CEDEX 26903 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 26903 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN |
| Generic Name | UNKNOWN |
| Product Code | JDY |
| Date Received | 2016-01-12 |
| Model Number | N/A |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET FRANCE S.A.R.L. |
| Manufacturer Address | PLATEAU DE LAUTAGNE BP75 VALENCE CEDEX 26903 FR 26903 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2016-01-12 |