MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2008-07-09 for UNIVERSAL TOTAL WRIST SYSTEM manufactured by Integra Lifesciences Corporation.
[20621236]
The reporter stated that a patient who received a universal total wrist system for slac (scapholunate advanced collapse) had to undergo revision surgery because of septic loosening. The revision procedure showed a loosening of two screws of the carpal component and one screw of the radial component. Inflammation of the bone was seen predominately along the two screws of the carpal component, but also in other areas of the wrist. An interim cement spacer was placed in the wrist after the explantation procedure. Information received in writing by integra indicates that the patient had no other pre-existing medical conditions, and that microbiology findings from the explanted devices are not available. The three universal total wrist system components reported in this event are: radial implant large right (catalogue number: 263400r lot number: 7672). Carpal implant large (catalogue number: 261401, lot number: 9016). Carpal poly implant large (catalogue number: 262400, lot number: 785).
Patient Sequence No: 1, Text Type: D, B5
[20831858]
To date, the device components involved in the reported incident have not been received for evaluation. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004608878-2008-00047 |
| MDR Report Key | 1074913 |
| Report Source | 01,08 |
| Date Received | 2008-07-09 |
| Date of Report | 2008-07-09 |
| Date of Event | 2008-06-01 |
| Date Added to Maude | 2009-09-11 |
| 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 | 0 |
| Manufacturer Contact | SUSAN SCOTT, RN |
| Manufacturer Street | 311C ENTERPRISE DR |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099363604 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Street | 4900 CHARLEMAR DR., BUILDING A |
| Manufacturer City | CINCINNATI OH 45227 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 45227 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIVERSAL TOTAL WRIST SYSTEM |
| Generic Name | PROSTHESIS, WRIST 3 PART METAL PLASTIC |
| Product Code | KWM |
| Date Received | 2008-07-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | CINCINNATI OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-07-09 |