MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2013-02-27 for NUGRIP SZ.40L NUG-443-40L manufactured by Ascension Orthopedics.
[18845704]
Patient had nugrip arthroplasty on the right thumb on (b)(6) 2012. Status post right thumb nugrip arthroplasty, the patient initially had no pain but then later on developed persistent pain and decrease in strength. Radiographs revealed some radiolucency around the implant but overall it appeared to be well placed. The patient did have an underlying carpal tunnel that was released and that did not help the pain. Due to the persistent pain, it was elected that the patient needed revision. The patient was revised on (b)(6) 2012, and had a aright thumb removal of the implant and right thumb tendon interposition sling arthroplasty with flexor carpi radialis tendon. The nugrip prostheses was removed. There was a large amount of gelatinous fibrous tissue that was also removed. It was reported that the implant that was well seated was certainly not loose.
Patient Sequence No: 1, Text Type: D, B5
[19288911]
The device involved in the reported incident is not expected to be received for evaluation. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2013-00002 |
| MDR Report Key | 2984900 |
| Report Source | 05,06,07 |
| Date Received | 2013-02-27 |
| Date of Report | 2013-02-27 |
| Date Mfgr Received | 2013-02-08 |
| Date Added to Maude | 2013-03-04 |
| 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 | ROWENA SALVADOR |
| Manufacturer Street | 315 ENTERPRISE DR. |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUGRIP SZ.40L |
| Generic Name | NUGRIP |
| Product Code | KYI |
| Date Received | 2013-02-27 |
| Catalog Number | NUG-443-40L |
| Lot Number | 10-1216 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENSION ORTHOPEDICS |
| Manufacturer Address | AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-02-27 |