MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-03-28 for MPF 75001002 manufactured by Smith&nephew - Switzerland.
[21755402]
It was reported that a revision surgery was performed due to implant breakage.
Patient Sequence No: 1, Text Type: D, B5
[21895411]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9613369-2013-00027 |
| MDR Report Key | 3025557 |
| Report Source | 07 |
| Date Received | 2013-03-28 |
| Date of Report | 2013-03-26 |
| Date of Event | 2013-03-13 |
| Date Mfgr Received | 2013-03-26 |
| Device Manufacturer Date | 2003-05-02 |
| Date Added to Maude | 2013-03-28 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR PHILLIP EMMERT |
| Manufacturer Street | 1450 E. BROOKS RD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013995296 |
| Manufacturer G1 | SMITH&NEPHEW - SWITZERLAND |
| Manufacturer Street | SCHACHENALLEE 29 |
| Manufacturer City | AARAU CH5000 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH5000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MPF |
| Generic Name | MPF CERAMIC INSERT STANDARD 41/32 |
| Product Code | LPF |
| Date Received | 2013-03-28 |
| Catalog Number | 75001002 |
| Lot Number | 033030 |
| Device Expiration Date | 2010-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH&NEPHEW - SWITZERLAND |
| Manufacturer Address | SCHACHENALLEE 29 AARAU CH5000 CH5000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2013-03-28 |