MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-06-08 for UNKNOWN EXTREMITY N/A manufactured by Biomet Orthopedics.
[46824190]
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. The following could not be completed with the limited information provided. Date of event - ni, device product code - ni, expiration date - ni, date implanted - ni, date explanted - ni, manufacture date? Ni. Event is being reported to fda on one medwatch as the limited information available indicates that a revision procedure is (or may be) needed. Should additional information be received regarding a revision procedure, the complaint will be reassessed and further medwatch reports will be submitted, if necessary.
Patient Sequence No: 1, Text Type: N, H10
[46824191]
A wrist revision procedure has been indicated due to an unknown reason; however, no revision procedure has been reported to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2016-01974 |
| MDR Report Key | 5706961 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-06-08 |
| Date of Report | 2016-05-09 |
| Date Mfgr Received | 2016-05-09 |
| Date Added to Maude | 2016-06-08 |
| 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 | MS. MEGAN HAAS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743726700 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 E. 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 | UNKNOWN EXTREMITY |
| Generic Name | PROSTHESIS, WRIST |
| Product Code | KXE |
| Date Received | 2016-06-08 |
| Model Number | N/A |
| Catalog Number | NI |
| Lot Number | NI |
| 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 | 1. Required No Informationntervention | 2016-06-08 |