MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,02,07 report with the FDA on 2010-10-21 for KINEMATIC UNK manufactured by Stryker Orthopaedics Limerick.
[21783631]
It was reported that, "a stryker hinged knee was revised following complications of fracture, hematoma, deep infection, and above the knee amputation. Awareness occurred as a result of reviewing the data set submitted as part of a retrospective clinical study".
Patient Sequence No: 1, Text Type: D, B5
[21859541]
An eval of the device cannot be performed as the device was not returned to the mfr. Additional info was requested. If it becomes available, the eval summary will be submitted in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610726-2010-00376 |
| MDR Report Key | 1884442 |
| Report Source | 00,02,07 |
| Date Received | 2010-10-21 |
| Date of Report | 2010-10-07 |
| Date of Event | 2010-10-06 |
| Date Mfgr Received | 2010-10-07 |
| Date Added to Maude | 2010-10-29 |
| 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 | RITA INTORELLA |
| 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 BUSNIESS 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 |
| Generic Name | IMPLANT |
| Product Code | LGE |
| Date Received | 2010-10-21 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | NA |
| 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 | 2010-10-21 |