MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-11 for UNIVERSAL 2 26-3100R, 26-2101 manufactured by Integra Lifesciences Corporation.
[120243806]
Wrist implant failure causing heavy metallosis, and product failure causing ruptured finger tendons. Metal on metal from universal 2 implanted in 2008, removed in 2018. Company: integra lifesciences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079719 |
| MDR Report Key | 7868796 |
| Date Received | 2018-09-11 |
| Date of Report | 2018-09-07 |
| Date of Event | 2017-11-01 |
| Date Added to Maude | 2018-09-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNIVERSAL 2 |
| Generic Name | UNIVERSAL TOTAL WRIST SYSTEM |
| Product Code | JWI |
| Date Received | 2018-09-11 |
| Model Number | 26-3100R, 26-2101 |
| Lot Number | 077132, 077127 |
| Device Expiration Date | 2013-01-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2018-09-11 |