MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-05-28 for NOVATION 170-32-03 manufactured by Exactech Inc.
[3522223]
Revision of hip components due to wear and osteolysis.
Patient Sequence No: 1, Text Type: D, B5
[10682958]
Engineering evaluation of the returned device is ongoing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1038671-2013-00048 |
| MDR Report Key | 3143226 |
| Report Source | 07 |
| Date Received | 2013-05-28 |
| Date of Report | 2013-05-28 |
| Date of Event | 2012-07-09 |
| Date Mfgr Received | 2013-05-08 |
| Date Added to Maude | 2013-06-06 |
| 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 | MELISSA CHRISTENSEN |
| Manufacturer Street | 2320 N.W. 66TH CT. |
| Manufacturer City | GAINESVILLE FL 32653 |
| Manufacturer Country | US |
| Manufacturer Postal | 32653 |
| Manufacturer Phone | 8003922832 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOVATION |
| Generic Name | BIOLOX DELTA FEMORAL HEAD |
| Product Code | KXD |
| Date Received | 2013-05-28 |
| Returned To Mfg | 2013-05-08 |
| Catalog Number | 170-32-03 |
| Lot Number | 1997024 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EXACTECH INC |
| Manufacturer Address | 2320 N.W. 66TH CT. GAINESVILLE FL 32653 US 32653 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-05-28 |