MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-10 for DIRECTINJECT ON DEMAND HA CEMENT 79-45905 manufactured by Stryker Orthopaedics-limerick.
[47194846]
Device is not available for evaluation. If additional information is received it will be reported on a supplemental report. Device remains implanted in patient.
Patient Sequence No: 1, Text Type: N, H10
[47194847]
It was reported that after a procedure conducted at the user facility the patient experienced an infection at the wound site postoperatively. Antibiotic treatment was administered to the wound site which remedied the infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008010177-2016-00123 |
| MDR Report Key | 5718478 |
| Date Received | 2016-06-10 |
| Date of Report | 2016-05-20 |
| Date of Event | 2016-04-04 |
| Date Mfgr Received | 2016-05-20 |
| Date Added to Maude | 2016-06-10 |
| 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 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 | 0 |
| Brand Name | DIRECTINJECT ON DEMAND HA CEMENT |
| Generic Name | IMPLANT |
| Product Code | GXP |
| Date Received | 2016-06-10 |
| Catalog Number | 79-45905 |
| Lot Number | DI16019 |
| Device Availability | N |
| 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 | 2016-06-10 |