MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2015-11-17 for UNKNOWN DEPUY LCS STD FEMUR UNK-KNEE manufactured by Depuy Orthopaedics, Inc..
[31369207]
Depuy synthes has been informed that the catalog number and lot number is not available. This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[31369208]
Patient was revised to address tibial tray loosening at the cement to implant interface and possible infection. Unknown cement was used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2015-35320 |
| MDR Report Key | 5229420 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2015-11-17 |
| Date of Report | 2015-11-04 |
| Date of Event | 2015-11-04 |
| Date Mfgr Received | 2015-11-04 |
| Date Added to Maude | 2015-11-17 |
| 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 | CHAD GIBSON |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN DEPUY LCS STD FEMUR |
| Generic Name | KNEE FEMORAL COMPONENT |
| Product Code | HSA |
| Date Received | 2015-11-17 |
| Catalog Number | UNK-KNEE |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-11-17 |