MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-10 for HYDROSET INJECTABLE CEMENT KIT 3CC 397003 manufactured by Stryker Orthopaedics-limerick.
[44889031]
Device is not available for evaluation. If additional information is received it will be reported on a supplemental report. Implant is not available for return.
Patient Sequence No: 1, Text Type: N, H10
[44889032]
It was reported by the patient that the red raised area of a previously operated tibia plateau fracture had opened up. The patient alleges this has happened on two other occasions. The patient further alleges that a portion of the hydroset was found in the wound. Additional information was acquired stating that the patient had an infection post op. The infection was treated with a drain and antibiotics during a follow up visit at the user facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008010177-2016-00094 |
| MDR Report Key | 5645142 |
| Date Received | 2016-05-10 |
| Date of Report | 2016-04-01 |
| Date of Event | 2016-01-09 |
| Date Mfgr Received | 2016-04-15 |
| Date Added to Maude | 2016-05-10 |
| 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 | 3 |
| Manufacturer Contact | MR. HANS GEIGER |
| Manufacturer Street | BOETZINGERSTR. 41 |
| Manufacturer City | FREIBURG D-79111 |
| Manufacturer Postal | D-79111 |
| Manufacturer Phone | 76145120 |
| Manufacturer G1 | STRYKER LEIBINGER FREIBURG |
| Manufacturer Street | BOETZINGERSTR. 41 |
| Manufacturer City | FREIBURG D-79111 |
| Manufacturer Postal Code | D-79111 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HYDROSET INJECTABLE CEMENT KIT 3CC |
| Generic Name | INJECTABLE BONE CEMENT |
| Product Code | GXP |
| Date Received | 2016-05-10 |
| Catalog Number | 397003 |
| Lot Number | IC01753 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ORTHOPAEDICS-LIMERICK |
| Manufacturer Address | RAHEEN BUSINESS PARK LIMERICK NA NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-10 |