MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,02,07 report with the FDA on 2013-05-30 for manufactured by Synthes Monument.
[3528625]
(b)(4) study patient initially presented with a fracture of the left lateral condyle of the tibia sustained in a fall on (b)(6) 2011. Patient was implanted with a proximal tibia plate and norian drillable cement on (b)(6) 2011. Patient experienced several infections and continued to complain of pain for two years. The patient was returned to the or on (b)(6) 2013 for removal of hardware and revision to a total knee replacement. At 6 weeks post revision, the patient was still complaining of pain. This report is #1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10682747]
Additional narrative: device is used for treatment, not diagnosis. Could not be determined without a part number. Investigation could not be completed, no conclusion could be drawn as no device was returned and no lot number was provided. Manufacturing records could not be reviewed without a lot number.
Patient Sequence No: 1, Text Type: N, H10
[19400130]
Device used for treatment, not diagnosis. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1719045-2013-01500 |
| MDR Report Key | 3138384 |
| Report Source | 01,02,07 |
| Date Received | 2013-05-30 |
| Date of Report | 2013-05-03 |
| Date of Event | 2011-04-07 |
| Date Mfgr Received | 2013-05-14 |
| Date Added to Maude | 2013-05-30 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JODI TEMPLE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Manufacturer G1 | SYNTHES MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVENUE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | OIS |
| Date Received | 2013-05-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES MONUMENT |
| Manufacturer Address | 1101 SYNTHES AVENUE MONUMENT CO 80132 US 80132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-05-30 |