MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2008-08-28 for KMI CEMENT RESTRICTOR IMPLANT 100032 manufactured by Integra Lifesciences Corporation.
[17017242]
The reporter stated that she had a local reaction to the product that was implanted. The product was implanted in a procedure intended to alleviate symptoms of osteoarthritis in her thumb at the base joint. Since the first surgical procedure she reports having inflammation, swelling of the top part of the thumb, and pain at rest. A second surgical procedure was performed in 2008, after which the reporter was advised that she had a foreign body reaction, that the base of the thumb joint is eroded away and that one bone is riding over another.
Patient Sequence No: 1, Text Type: D, B5
[17233623]
To date, the device involved in the reported incident has 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 | 3004608878-2008-00072 |
| MDR Report Key | 1140108 |
| Report Source | 04 |
| Date Received | 2008-08-28 |
| Date of Report | 2008-08-28 |
| Date of Event | 2007-02-12 |
| Date Mfgr Received | 2008-07-31 |
| Date Added to Maude | 2008-09-08 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SUSAN SCOTT, RN |
| Manufacturer Street | 311C ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099363604 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Street | 4900 CHARLEMAR DRIVE 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 | KMI CEMENT RESTRICTOR IMPLANT |
| Generic Name | CEMENT RESTRICTOR |
| Product Code | JDK |
| Date Received | 2008-08-28 |
| Catalog Number | 100032 |
| Lot Number | 50928-02 |
| Device Expiration Date | 2007-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1160995 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | CINCINNATI OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-08-28 |