MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-10-31 for MITCH TRH? MODULAR HEAD 50MM +8MM NECK OEMSYKMMH99881850 manufactured by Finsbury Orthopaedics Limited.
| Report Number | 1818910-2019-113120 |
| MDR Report Key | 9262864 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-10-31 |
| Date of Report | 2019-10-04 |
| Date of Event | 2019-03-29 |
| Date Mfgr Received | 2019-11-19 |
| Device Manufacturer Date | 2006-10-17 |
| Date Added to Maude | 2019-10-31 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 1210 WARD AVENUE |
| Manufacturer City | WEST CHESTER IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | FINSBURY ORTHOPAEDICS LIMITED |
| Manufacturer Street | 13 MOLE BUSINESS PARK RANDALLS ROAD |
| Manufacturer City | LEATHERHEAD, SURREY KT227BA |
| Manufacturer Country | UK |
| Manufacturer Postal Code | KT227BA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MITCH TRH? MODULAR HEAD 50MM +8MM NECK |
| Generic Name | MITCH TRH IMPLANT : HIP ACETABULAR METAL HEMI |
| Product Code | KWB |
| Date Received | 2019-10-31 |
| Returned To Mfg | 2019-10-11 |
| Catalog Number | OEMSYKMMH99881850 |
| Lot Number | FM067801 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FINSBURY ORTHOPAEDICS LIMITED |
| Manufacturer Address | 13 MOLE BUSINESS PARK, RANDALL LEATHERHEAD, SURREY KT227BA UK KT227BA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-10-31 |