MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2012-03-12 for HEAD CERAMIC O 28 MM 75000992 manufactured by Smith And Nephew- Switzerland.
[2630972]
It was reported that a revision surgery was performed due to fracturing of the device.
Patient Sequence No: 1, Text Type: D, B5
[9675948]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9613369-2012-00016 |
| MDR Report Key | 2488287 |
| Report Source | * |
| Date Received | 2012-03-12 |
| Date of Report | 2012-03-06 |
| Date of Event | 2012-01-20 |
| Date Mfgr Received | 2012-03-06 |
| Date Added to Maude | 2012-03-12 |
| 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 | MR PHILLIP EMMERT |
| Manufacturer Street | 1450 E. BROOKS RD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013995296 |
| Manufacturer G1 | SMITH AND NEPHEW - SWITZERLAND |
| Manufacturer Street | SCHACHENALLEE 29 |
| Manufacturer City | AARAU CH5000 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH5000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEAD CERAMIC O 28 MM |
| Generic Name | HIP PROSTHESIS |
| Product Code | LPF |
| Date Received | 2012-03-12 |
| Catalog Number | 75000992 |
| Lot Number | 003045 |
| Device Expiration Date | 2009-04-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH AND NEPHEW- SWITZERLAND |
| Manufacturer Address | SCHACHENALLEE 29 AARAU CH5000 SZ CH5000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2012-03-12 |