MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-27 for ARH SOLUTIONS HEAD 20MM, RIGHT 5001-0220R-S manufactured by Acumed Llc.
[182229712]
Additional mdrs associated with this event: 3025141-2020-00042: neck, 3025141-2020-00044: stem.
Patient Sequence No: 1, Text Type: N, H10
[182229713]
The patient had a radial head replacement with the arh slide-loc replacement system on (b)(6) 2017. Post op, the patient complained of pain, decreased function and clicking in the right elbow. X-ray revealed the components of the device had become loosened. Revision surgery to remove the device was performed on (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3025141-2020-00043 |
| MDR Report Key | 9763838 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-14 |
| Date Mfgr Received | 2020-02-14 |
| Device Manufacturer Date | 2016-03-02 |
| Date Added to Maude | 2020-02-27 |
| 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 Phone | 8886279957 |
| Manufacturer G1 | ACUMED LLC |
| 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 |
| Brand Name | ARH SOLUTIONS HEAD 20MM, RIGHT |
| Generic Name | PROSTHESIS, ELBOW, HEMI-, RADIAL: HEAD |
| Product Code | KWI |
| Date Received | 2020-02-27 |
| Model Number | 5001-0220R-S |
| Catalog Number | 5001-0220R-S |
| Lot Number | 372654 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACUMED LLC |
| Manufacturer Address | 5885 NE CORNELIUS PASS ROAD HILLSBORO OR 97124 US 97124 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-27 |