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 2019-12-23 for FEMORAL HEAD/NECK IMPACTOR 71360093 manufactured by Smith & Nephew, Inc..
[177215094]
It was reported that during a thr procedure, upon impacting the head on to the femoral implant the impactor's black plastic part broke over the incision. The piece was found and nothing was left in the patient. The head was firmly attached to the stem. There was an s&n backup device available. There were no delays in the procedure and no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2019-04560 |
| MDR Report Key | 9511147 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-12-23 |
| Date of Report | 2020-03-10 |
| Date of Event | 2019-11-26 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2017-03-20 |
| Date Added to Maude | 2019-12-23 |
| 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 | FEMORAL HEAD/NECK IMPACTOR |
| Generic Name | PROSTH, HIP, SEMI-CONSTRA, UNCEMENT, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE |
| Product Code | MEH |
| Date Received | 2019-12-23 |
| Model Number | 71360093 |
| Catalog Number | 71360093 |
| Lot Number | 17CM14260 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| 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 | 2019-12-23 |