MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2013-09-03 for UNKNOWN DEPUY PATELLA UNK-KNEE manufactured by 1818910 Depuy Orthopaedics, Inc..
[3958730]
Patient was revised to address loosening of the femoral component and the tibial tray at both interfaces. The tibial tray had also subsided. The manufacturer of the cement used at the time of original implantation is unknown. Update (b)(6) 2013 - patient's revision operative records were received. Records indicate osteolysis was found as well as yellow bloody fluid in the joint. The patient's patella and insert are being reported.
Patient Sequence No: 1, Text Type: D, B5
[11130439]
This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed.
Patient Sequence No: 1, Text Type: N, H10
[27680264]
The device associated with this report was not returned. Requests for additional investigational inputs were made in accordance with wi-7915 appendix a. Patient medical records and x-rays were provided. Review of the supplied investigational inputs confirmed osteolysis and loosening of the femoral and tibial component. Review of the device history records and/or a complaint database search was not possible as the product and lot codes required were not provided. The investigation could not draw any conclusions about the root cause of the osteolysis or the loosened femoral and tibial component based on the provided information. Based on the inability to determine a root cause, the need for corrective action was not indicated. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2013-25801 |
| MDR Report Key | 3321458 |
| Report Source | 05,08 |
| Date Received | 2013-09-03 |
| Date of Report | 2013-08-06 |
| Date of Event | 2013-06-20 |
| Date Mfgr Received | 2014-05-20 |
| Date Added to Maude | 2013-09-03 |
| 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 | STACEY TRICK |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| Manufacturer Phone | 5743714554 |
| Manufacturer G1 | 1818910 DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46581 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN DEPUY PATELLA |
| Generic Name | PATELLA |
| Product Code | HSH |
| Date Received | 2013-09-03 |
| Catalog Number | UNK-KNEE |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 1818910 DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Address | 700 ORTHOPAEDIC DR. WARSAW IN 46581 US 46581 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-09-03 |