MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-10 for TIE-IN(R) TRAPEZIUM IMPLANT 856-300X manufactured by Wright Medical Technology, Inc..
[59776608]
The investigation is not complete. Trends will be evaluated. This report will be updated when the investigation is complete. This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[59776609]
Per avisar et al 2015, "trapeziectomy with a tendon tie-in implant for osteoarthritis of the trapeziometarcarpal joint", there were two out of twenty-eight cases of prosthesis removal due to implant dislocation at 2 months and 3 months, respectively. Both patients recovered uneventfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043534-2016-00116 |
| MDR Report Key | 6093832 |
| Date Received | 2016-11-10 |
| Date of Report | 2016-11-08 |
| Date Facility Aware | 2016-11-07 |
| Date Mfgr Received | 2016-11-07 |
| Date Added to Maude | 2016-11-10 |
| 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 Street | 1023 CHERRY ROAD |
| Manufacturer City | MEMPHIS TN 38117 |
| Manufacturer Country | US |
| Manufacturer Postal | 38117 |
| Manufacturer Phone | 901451-631 |
| Manufacturer G1 | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Street | 11576 MEMPHIS ARLINGTON RD |
| Manufacturer City | ARLINGTON TN 38002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TIE-IN(R) TRAPEZIUM IMPLANT |
| Generic Name | SMALL JOINT COMPONENT |
| Product Code | KYI |
| Date Received | 2016-11-10 |
| Model Number | 856-300X |
| Lot Number | NI |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Address | 11576 MEMPHIS ARLINGTON RD ARLINGTON TN 38002 US 38002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-11-10 |