MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,05,07 report with the FDA on 2013-08-27 for NUGRIP SZ. 20M NUG-443-20M manufactured by Ascension Orthopedics, Inc..
[3700421]
It was reported the patient was enrolled in a clinical study. Initial surgery of right thumb arthroscopy with nugrip prosthesis implant was performed on (b)(6) 2012 "one year post-operatively the patient was noted to experience "increasing pain with pinch". Radiograph revealed an erosion of the implant into the trapezium with loss of height of the space between the trapezium and the metacarpal. There is also some wallowing of the prosthesis in the shaft of the metacarpal. The erosion has gotten quite close to actually eroding through the trapezium itself to the scaphoid joint. " a revision surgery and implant removal was performed on (b)(6) 2013 for a diagnosis of "right nugrip prosthesis hardware failure, loosening, aseptic.
Patient Sequence No: 1, Text Type: D, B5
[11185078]
The device involved in the reported incident is not available for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2013-00026 |
| MDR Report Key | 3322399 |
| Report Source | 02,05,07 |
| Date Received | 2013-08-27 |
| Date of Report | 2013-08-27 |
| Date Mfgr Received | 2013-08-06 |
| Date Added to Maude | 2013-09-04 |
| 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 | CAREN FINKELSTEIN |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Manufacturer G1 | ASCENSION ORTHOPEDICS, INC. |
| Manufacturer Street | 8700 CAMERON RD., STE. 100 |
| Manufacturer City | AUSTIN TX 78754383 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78754 3832 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUGRIP SZ. 20M |
| Generic Name | NUGRIP |
| Product Code | KYI |
| Date Received | 2013-08-27 |
| Catalog Number | NUG-443-20M |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENSION ORTHOPEDICS, INC. |
| Manufacturer Address | 8700 CAMERON RD., STE. 100 AUSTIN TX 78754383 US 78754 3832 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-08-27 |