MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-06-25 for HYDROSET INJECTABLE CEMENT KIT 15CC 397015 manufactured by Stryker Orthopaedics-limerick.
[112165186]
Device is not available for evaluation. If additional information is received it will be reported on a supplemental report. Device cannot be sterilized so returning is not an option.
Patient Sequence No: 1, Text Type: N, H10
[112165187]
It was reported that patient's right hip was revised. As reported by rep: "patient had an infection and had some components exchanged during the i and d".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008010177-2018-00055 |
| MDR Report Key | 7633657 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-06-25 |
| Date of Report | 2018-10-12 |
| Date of Event | 2018-05-30 |
| Date Mfgr Received | 2018-05-30 |
| Device Manufacturer Date | 2017-11-23 |
| Date Added to Maude | 2018-06-25 |
| 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. KELLI DYKSTRA |
| Manufacturer Street | BOETZINGERSTR. 41 |
| Manufacturer City | FREIBURG D-79111 |
| Manufacturer Postal | D-79111 |
| Manufacturer Phone | 76145120 |
| Manufacturer G1 | STRYKER ORTHOPAEDICS-LIMERICK |
| Manufacturer Street | RAHEEN BUSINESS PARK |
| Manufacturer City | LIMERICK NA |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYDROSET INJECTABLE CEMENT KIT 15CC |
| Generic Name | IMPLANT |
| Product Code | GXP |
| Date Received | 2018-06-25 |
| Catalog Number | 397015 |
| Lot Number | VB5S7 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Required No Informationntervention | 2018-06-25 |