MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2013-05-01 for UNKNOWN DEPUY SIGMA SZ 2.5 CR FEMUR UNK-KNEE manufactured by 1818910 Depuy Orthopaedics, Inc..
[3290474]
Patient was revised to address pain.
Patient Sequence No: 1, Text Type: D, B5
[10875796]
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
[20420011]
The device associated with this report was not returned. Review of the device history records and/or a lot specific complaint database search was not possible as the product code and lot code required was not provided. Requests for additional investigational inputs were made: however, no additional information was obtained. The investigation could not draw any conclusions regarding the reported event with the information available. 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 the product and/or additional information be received, the investigation will be re-opened.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2013-16359 |
| MDR Report Key | 3087212 |
| Report Source | 05,08 |
| Date Received | 2013-05-01 |
| Date of Report | 2013-04-22 |
| Date of Event | 2013-04-22 |
| Date Mfgr Received | 2013-04-22 |
| Date Added to Maude | 2013-05-01 |
| 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 SIGMA SZ 2.5 CR FEMUR |
| Generic Name | FEMORAL KNEE PROSTHESIS |
| Product Code | HSA |
| Date Received | 2013-05-01 |
| 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 | 2013-05-01 |