MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2020-02-21 for LEFT ANTEVERTED MODULAR NECK 71352116 manufactured by Smith & Nephew, Inc..
[180785738]
It was reported that a revision surgery was performed due to left hip trunionosis with metal debris. Liner, head and stem were removed. The metal debris were caused by the interaction in between the titanium stem and the co-cr neck.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2020-00679 |
| MDR Report Key | 9741869 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-21 |
| Date of Event | 2019-07-22 |
| Date Mfgr Received | 2020-02-10 |
| Device Manufacturer Date | 2010-10-20 |
| Date Added to Maude | 2020-02-21 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | LEFT ANTEVERTED MODULAR NECK |
| Generic Name | PROST, HIP, SEMI-CONS, UNCEME, METAL/POLY, NON-PORO, CAL-PHOSP |
| Product Code | MEH |
| Date Received | 2020-02-21 |
| Model Number | 71352116 |
| Catalog Number | 71352116 |
| Lot Number | 09KTM0019A |
| Device Availability | * |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2020-02-21 |