MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-04-14 for R3 71338952 manufactured by Smith And Nephew, Inc..
[1868381]
It was reported that a revision surgery was performed.
Patient Sequence No: 1, Text Type: D, B5
[9108169]
In the initial mdr, it was reported (b)(4) as the legal manufacturer. This information is incorrect. The legal manufaturer should be 8010764, our germany manufacturer site.
Patient Sequence No: 1, Text Type: N, H10
[9113000]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020279-2011-00130 |
| MDR Report Key | 2055194 |
| Report Source | 05,07 |
| Date Received | 2011-04-14 |
| Date of Report | 2011-04-13 |
| Date of Event | 2011-04-06 |
| Date Mfgr Received | 2011-03-21 |
| Device Manufacturer Date | 2009-12-01 |
| Date Added to Maude | 2011-04-14 |
| 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 (GERMANY) ORTHOPAEDICS |
| Manufacturer Street | ALEMANNENSTRASSE 14 |
| Manufacturer City | TUTTLINGEN TN 38116785 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 38116 7853 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | R3 |
| Generic Name | ACETABULAR SHELL |
| Product Code | LPF |
| Date Received | 2011-04-14 |
| Catalog Number | 71338952 |
| Lot Number | 09MT38082 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH AND NEPHEW, INC. |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-14 |