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.
[154003168]
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information. Doi 10. 1007/s00256-017-2648-z.
Patient Sequence No: 1, Text Type: N, H10
[154003169]
Skeletal radiol (2017) published: "radiographic interpretation of carpometacarpal arthroplasty: correlation between radiographic loosening and clinical outcome". Purpose: the purpose of this case series was to assess the radiographic appearance and interpretation of loosening in patients following first carpometacarpal joint pyrohemisphere arthroplasty. Methods: a retrospective review over a 6-year period was performed identifying patients with first carpometacarpal pyrohemisphere implants. All postoperative radiographs were reviewed and compared with clinical information. Loosening was defined as greater than 1 mm of periprosthetic lucency or increasing lucency on serial studies. Adverse clinical outcome was defined as infection, complex regional pain syndrome, subluxation or an inability to return to activities of daily living. Statistical analysis included cohen? S kappa coefficient to measure inter-reader agreement for radiographic interpretation and the agreement between radiographic loosening and an undesired or adverse clinical outcome. Results: thirty-one implants in 26 patients were reviewed. A total of 73 postoperative radiographs were reviewed. The mean age of the study subjects was 58 years. The mean radiographic follow-up was 13 months (range: 1? 56). All arthroplasties were performed for osteoarthritis. Only one repeat surgery was performed. Adverse event: five patients in the study, for a total of 6 implants, complained of adverse clinical outcomes: one (1) - postoperative infection, one (1) - complex regional pain syndrome, two (2) - subluxation - one had revision surgery, two (2) - unable to return to activities of daily living. Conclusions: although radiography may be useful in the correct clinical context, it should not be utilized as the sole predictor of adverse clinical outcomes following carpometacarpal arthroplasty.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651501-2019-00028 |
| MDR Report Key | 8875566 |
| Report Source | LITERATURE |
| Date Received | 2019-08-08 |
| Date of Report | 2019-07-17 |
| Date Mfgr Received | 2019-08-08 |
| 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 Age | DA |
| 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 |