MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-03-27 for R3 71338954 manufactured by Smith And Nephew - Germany.
[18501988]
It was reported that a revision surgery was reported for implant breakage.
Patient Sequence No: 1, Text Type: D, B5
[18680333]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010764-2012-00016 |
| MDR Report Key | 2506485 |
| Report Source | 07 |
| Date Received | 2012-03-27 |
| Date of Report | 2012-03-07 |
| Date of Event | 2012-03-13 |
| Date Mfgr Received | 2013-04-03 |
| Device Manufacturer Date | 2009-06-01 |
| Date Added to Maude | 2012-03-28 |
| 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 | 0 |
| 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&NEPHEW |
| Manufacturer Street | ALEMANNENSTRASSE 14 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | R3 |
| Generic Name | R3 36MM ID US CRMC LINER 54 |
| Product Code | LPF |
| Date Received | 2012-03-27 |
| Returned To Mfg | 2013-04-02 |
| Catalog Number | 71338954 |
| Lot Number | 09FT32751 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH AND NEPHEW - GERMANY |
| Manufacturer Address | ALEMANNENSTRASSSE 14 TUTTLINGEN 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2012-03-27 |