MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-01-28 for PROSTHESIS, ELBOW, HEMI-, RADIAL - HEAD manufactured by Acumedllc.
[183717113]
Additional mdrs associated with this event: 3025141-2020-00017: neck, 3025141-2020-00018: stem.
Patient Sequence No: 1, Text Type: N, H10
[183717114]
Patient received a arh slide loc radial head replacement system about 2 year ago. Patient presented with increased pain. X-ray showed the device to be dissociated. It will be revised in a second surgery on (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5
[188938441]
3025141-2020-00017 follow up 1: neck; 3025141-2020-00018 follow up 1: stem.
Patient Sequence No: 1, Text Type: N, H10
[188938442]
Patient received an arh slide loc roadial head replacement in (b)(6) of 2017. Patient presented with increased pain recently. X-ray showed the device to dissociated. It was revised in a second surgery on "(b)(6) 220" to an arh solutions 2 replacement system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3025141-2020-00016 |
| MDR Report Key | 9637582 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-01-28 |
| Date of Report | 2020-01-30 |
| Date Mfgr Received | 2020-01-30 |
| Date Added to Maude | 2020-01-28 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MICKI ANDERSON |
| Manufacturer Street | 5885 NE CORNELIUS PASS ROAD |
| Manufacturer City | HILLSBORO OR 97124 |
| Manufacturer Country | US |
| Manufacturer Postal | 97124 |
| Manufacturer G1 | ACUMEDLLC |
| Manufacturer Street | 5885 NE CORNELIUS PASS ROAD |
| Manufacturer City | HILLSBORO OR 97124 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 97124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | PROSTHESIS, ELBOW, HEMI-, RADIAL - HEAD |
| Product Code | KWI |
| Date Received | 2020-01-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACUMEDLLC |
| Manufacturer Address | 5885 NE CORNELIUS PASS ROAD HILLSBORO OR 97124 US 97124 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-28 |