MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2010-10-25 for KINEMATIC II UNK manufactured by Stryker Orthopaedics Limerick.
[18972462]
It was reported that, "k ii was revised following a complication of deep infection. Awareness occurred as the result of reviewing the date set submitted as part of a retrospective clinical study. "
Patient Sequence No: 1, Text Type: D, B5
[18990660]
An evaluation of the device cannot be performed as the device was not returned to the manufacturer. Additional information was requested. If it becomes available, the evaluation summary will be submitted in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610726-2010-00387 |
| MDR Report Key | 1885714 |
| Report Source | 00,07 |
| Date Received | 2010-10-25 |
| Date of Report | 2010-10-06 |
| Date of Event | 2010-10-06 |
| Date Mfgr Received | 2010-10-06 |
| Date Added to Maude | 2010-11-02 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | RITA INTORRELLA |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER ORTHOPAEDICS LIMERICK |
| Manufacturer Street | RAHEEN BUSINESS PARK |
| Manufacturer City | LIMERICK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KINEMATIC II |
| Generic Name | IMPLANT |
| Product Code | LGE |
| Date Received | 2010-10-25 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ORTHOPAEDICS LIMERICK |
| Manufacturer Address | LIMERICK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-10-25 |