MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2019-08-08 for NUGRIP GENERIC manufactured by Ascension Orthopedics.
[153981265]
Dhr - no product lot information was provided; therefore, no dhr review is possible. As no device has been returned, no failure analysis can be performed. Based on the limited information received to date, the root cause for the reported event cannot be determined. Dx. Doi. Org/10. 1016/j. Rboe. 2016. 06. 003. Linked to mfg report number: 1651501-2019-00030, 1651501-2019-00031, 1651501-2019-00032, 1651501-2019-00034, 1651501-2019-00035.
Patient Sequence No: 1, Text Type: N, H10
[153981266]
Revista brasileira de ortopedia (2016) published: "measurement of quality of life among patient undergoing arthroplasty of the thumb to treat cmc arthritis". Purpose: the purpose of this case series was to present the clinical and functional results, including measurement of quality of life, of patients undergoing trapeziometacarpal arthroplasty. Methods: this was a prospective evaluation on 45 patients (53 thumbs) with a diagnosis of idiopathic rhizarthrosis who underwent resection arthroplasty and interposition of an uncemented implant, made of pyrocarbon. The clinical and functional results were analyzed through radiography, range of motion (rom) in degrees, visual analog scale (vas) for pain and the disability of arm, shoulder and hand (dash) questionnaire for quality of life. In the group analyzed, 38 were women and seven were men, and their mean age was 63. 17 years (range: 50? 78). Eight patients were treated bilaterally. Results: after 42. 08 months of follow-up (range: 8? 73), the subjective pain evaluation (vas) score was 1. 37 (range: 1? 4). The complete rom of the thumb increased to 95. 75% (range: 75? 100%) in relation to the contralateral side. The mean dash questionnaire score was 9. 98 (range: 1? 18). The complication rate (negative events) was 11. 32%. Five patients presented dislocation of the thumb prosthesis. All of them were reoperated by means of dorsal capsuloplasty using a portion of the retinaculum of the extensors as a graft, and good clinical evolution was achieved in these cases. One patient presented fracturing of the metacarpal and was treated by means of osteosynthesis using kirschner wires. Adverse event: patient #15: dislocation - patient underwent reoperation with the dorsal capsuloplasty technique, using a dorsal wrist retinaculum graft. The patient had a good clinical outcome. Male (b)(6) y/o. Dominance - dominant. Follow-up (months) - 56. Dash (disability the arm, shoulder, and hand) - 6. Rom (range of motion) - 80 degrees. Vas (visual analog score) - 1. Conclusions: this method is effective for treating rhizarthrosis, according to the measurements made on the clinical and functional results, even after taking the complication rate into consideration. Moreover, it provides an improvement of quality of life for these patients.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651501-2019-00033 |
| MDR Report Key | 8875569 |
| Report Source | LITERATURE |
| Date Received | 2019-08-08 |
| Date of Report | 2019-07-17 |
| Date Mfgr Received | 2019-07-17 |
| Date Added to Maude | 2019-08-08 |
| 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 | USER VIVIAN NELSON |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| 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 | NUGRIP GENERIC |
| Generic Name | NUGRIP |
| Product Code | KYI |
| Date Received | 2019-08-08 |
| Catalog Number | NUGRIP GENERIC |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-08-08 |