MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-11-29 for ARTICULAR SURFACE PROVISIONAL SZ 4 8MM 00584102408 manufactured by Smith & Nephew, Inc..
[168679600]
It was reported that during surgery, the trial seated correctly but snapped when the knee was flexed. All the pieces were recovered. There was a backup device available. There were no delays in the procedure and no patient injuries reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2019-04206 |
| MDR Report Key | 9392047 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-11-29 |
| Date of Report | 2019-11-29 |
| Date of Event | 2019-11-05 |
| Date Mfgr Received | 2019-11-05 |
| Device Manufacturer Date | 2005-03-18 |
| Date Added to Maude | 2019-11-29 |
| 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 | 3 |
| Manufacturer Contact | DR. SARAH FREESTONE |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 0447940038 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 1450 BROOKS ROAD |
| 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 | ARTICULAR SURFACE PROVISIONAL SZ 4 8MM |
| Generic Name | TEMPLATE |
| Product Code | HWT |
| Date Received | 2019-11-29 |
| Returned To Mfg | 2019-11-20 |
| Catalog Number | 00584102408 |
| Lot Number | 60284988 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-29 |