MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2017-09-15 for SYNPLUG CEMENT RESTRICTOR manufactured by Isotis Orthobiologics, Inc.
[86423182]
Event could not be confirmed. No radiographs were received. No product will be returned as it remains implanted, no product information was given and no further evaluation of the product can be completed at this time. Patient is asymptomatic. There is no current plan for revision.
Patient Sequence No: 1, Text Type: N, H10
[86423183]
Initial hip replacement (hip arthroplasty) surgery involving a hip prosthesis, thp cement, and synplug cement restrictor, occurred in 2012. Allegedly on (b)(6) 2017 during routine 5 year follow up patient presented discrete oesteolysis in the left hip. Patient attended all previously scheduled follow ups during the five years after hip total prosthesis surgery (left). He indicates good progress. Patient is active and mobile. Walking distances are limited to two hours also due to other problems (e. G. Heart). He doesn't report from any pain in the hip area and frequently uses walking sticks. Prosthesis component is firmly enclosed. Patient shows regular progress five years after above mentioned surgery. No remedial action planned. Surgeon will continue to monitor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2090010-2017-00004 |
| MDR Report Key | 6869711 |
| Report Source | FOREIGN |
| Date Received | 2017-09-15 |
| Date of Report | 2017-09-08 |
| Date of Event | 2017-08-28 |
| Date Mfgr Received | 2017-09-08 |
| Date Added to Maude | 2017-09-15 |
| 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 | PETER PERHACH |
| Manufacturer Street | 5770 ARMADA DR. |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| Manufacturer Phone | 7602165681 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNPLUG CEMENT RESTRICTOR |
| Generic Name | CEMENT OBTURATOR |
| Product Code | LZN |
| Date Received | 2017-09-15 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ISOTIS ORTHOBIOLOGICS, INC |
| Manufacturer Address | IRVINE CA 96218 US 96218 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-15 |