MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-07-01 for CARPAL POLY MEDIUM- STD. 262300 manufactured by Ascension Orthopedics.
[149708262]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[149708263]
It was reported initially an issue with the uni2 total wrist implant system (id 262300 - carpal poly medium- std. ). Additional information received on (b)(6) 2019 indicates that the prosthesis implantation was on (b)(6) 2015 for known arthrosis of the left wrist with rheumatoid arthritis. On (b)(6) 2019, there was a revision surgery in synovectomy of first extensor tendon section. The connection to the wrist shows clear synovitis upon closer inspection and removal of the synovial stratum of the polyethylene inlay on the dorsal side. Inlay sits firmly on the carpal component, no metal abrasion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651501-2019-00024 |
| MDR Report Key | 8750509 |
| Report Source | FOREIGN |
| Date Received | 2019-07-01 |
| Date of Report | 2019-06-03 |
| Date of Event | 2019-05-15 |
| Date Mfgr Received | 2019-09-04 |
| Device Manufacturer Date | 2011-04-29 |
| Date Added to Maude | 2019-07-01 |
| 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 | MRS. VIVIAN NELSON |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362319 |
| Manufacturer G1 | ASCENSION ORTHOPEDICS |
| Manufacturer Street | 8700 CAMERON ROAD #100 |
| Manufacturer City | AUSTIN TX 78754 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78754 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARPAL POLY MEDIUM- STD. |
| Generic Name | UNI2 TOTAL WRIST IMPLANT SYSTEM |
| Product Code | JWJ |
| Date Received | 2019-07-01 |
| Returned To Mfg | 2019-08-13 |
| Catalog Number | 262300 |
| Lot Number | 090831 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENSION ORTHOPEDICS |
| Manufacturer Address | 8700 CAMERON ROAD #100 8700 CAMERON ROAD #100 AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-01 |