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 2020-03-30 for OFFSET REF CUP POS/IMPACTOR 71364022 manufactured by Smith & Nephew, Inc..
[185722493]
It was reported that during a thr procedure, offset reflection cup pos/impactor broke upon impaction. All pieces recovered. A delay no greater than 30 min was reported. A backup device was available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2020-01079 |
| MDR Report Key | 9901834 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-30 |
| 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 | OFFSET REF CUP POS/IMPACTOR |
| Generic Name | PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL |
| Product Code | JDG |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-03-12 |
| Model Number | 71364022 |
| Catalog Number | 71364022 |
| Lot Number | 15MM08525 |
| 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 | 2020-03-30 |