MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-11-13 for RENOVATION UNK 71369007 manufactured by Smith & Nephew, Inc., Orthopaedic Div.
[20760196]
During a revision surgery, it was reported that or time was extended more than 30 mins.
Patient Sequence No: 1, Text Type: D, B5
[20804863]
Na
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020279-2006-00642 |
| MDR Report Key | 781007 |
| Report Source | 07 |
| Date Received | 2006-11-13 |
| Date of Report | 2006-10-10 |
| Date Mfgr Received | 2006-10-10 |
| Device Manufacturer Date | 2005-12-01 |
| Date Added to Maude | 2006-11-16 |
| 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 | 0 |
| Manufacturer Contact | MR. NICHOLAS TABRIZI, SPECIALIST |
| Manufacturer Street | 1450 BROOKS RD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013996017 |
| Manufacturer G1 | SMITH & NEPHEW INC. |
| Manufacturer Street | 1450 BROOKS RD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RENOVATION |
| Generic Name | FEMORAL COMPONENT |
| Product Code | LZV |
| Date Received | 2006-11-13 |
| Model Number | UNK |
| Catalog Number | 71369007 |
| Lot Number | 05MM07238 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 768786 |
| Manufacturer | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV |
| Manufacturer Address | 1450 BROOKS RD. MEMPHIS TN 38116 US |
| Baseline Brand Name | RENEVATION IMPLANT REMOVAL SYSTEM |
| Baseline Generic Name | CONICAL TAP |
| Baseline Model No | NA |
| Baseline Catalog No | 71369007 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2006-11-13 |