MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-03-14 for SYNPLUG CEMENT RESTRICTOR manufactured by Isotis Orthobioogics.
[138893851]
No remedial action planned for right side. Medical evaluation of received radiograph notes no loosening and no definite fractures observed. According to the medical report received the osteolysis in the radiological control is stationary, patient is without pain and the surgeon has elected to proceed with 2-year follow-ups. To date, there are no conclusive findings from this or similar complaint investigations, or from technical or clinical information in the literature that proves or disproves a causal relationship between synplug? & optiplug? Biodegradable cement restrictors or the materials they are manufactured with, and periprosthetic osteolysis (or fractures as a result). There are also no data or findings that would suggest that only some subset of all the products manufactured might be affected. The finding of osteolysis surrounding the distal cement restrictor is unexpected, and undesirable; however, periprosthetic osteolysis in total hip arthroplasty is a well-known problem that is typically a multifactorial process and may be identified through routine radiographic follow-up.
Patient Sequence No: 1, Text Type: N, H10
[138893852]
Initial hip replacement (hip arthroplasty) surgery involving a hip prosthesis, thp cement, and synplug cement restrictor, right side occurred in 2007. Planned clinical / radiographic follow-up 11 years postoperatively observed stationary osteolysis in the distal region of the right prosthetic. Device remains in the patient. No remedial action planned. Surgeon will continue to monitor every two-years. The patient reports that she was fine, that she is free of complaints. She could walk for two hours daily without any problems and is not restricted at all in everyday life.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2090010-2019-00001 |
| MDR Report Key | 8423116 |
| Report Source | FOREIGN |
| Date Received | 2019-03-14 |
| Date of Report | 2019-03-13 |
| Date of Event | 2018-11-30 |
| Date Mfgr Received | 2019-02-13 |
| Date Added to Maude | 2019-03-14 |
| 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 | AARON |
| Manufacturer Street | 2 GOODYEAR |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| 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 | 2019-03-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ISOTIS ORTHOBIOOGICS |
| Manufacturer Address | IRVINE CA 96218 US 96218 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-14 |