MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2016-04-21 for SYNPLUG CEMENT RESTRICTOR manufactured by Isotis Orthobiologics, Inc.
[43288315]
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, and the patient will continue to be monitored. Patient activity level is high. Patient's bone quality is unknown. It is unknown if the patient complied with post-operative care instructions. It is unknown if the concomitant device (hip prosthesis) or bone cement contributed to the event. The complaint database was reviewed and indicated there were other related complaints for osteolysis observation. 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. Device remains in-situ.
Patient Sequence No: 1, Text Type: N, H10
[43288316]
Patient came for 10-year-check as planned. Patient had hip transplant right (shaft weber ss, acetabulum firmore 56mm, inlay durasul 36). He is very satisfied with the development. He is without any discomfort on both hips and can do all things he wants to do. Surgeon evaluation: scar without irritation. Fluid walking pattern. Mobility of right hip flexion/extension 120/0/0? , inner rotation/outer rotation 10/0/20? , abduction/ adduction 60/0/45?. Mobility without pain of left hip joint. Small distal osteolysis, distal of shaft of femur. Surgeon's radiological evaluation: regular placement of hip transplant without any sign of loosening or implant failure. Small osteolysis distal of femur shaft. (radiograph was not provided for investigation) patient outcome: the progress is excellent after a total hip prosthesis implantation on the right. Patient is asymptomatic, and currently there is no plan for revision. Surgeon recommend the next check with x-ray in 5 years, i. E. 15 years after hip transplant implantation. Surgeon will continue to monitor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2090010-2016-00004 |
| MDR Report Key | 5596202 |
| Report Source | FOREIGN |
| Date Received | 2016-04-21 |
| Date of Report | 2016-04-13 |
| Date of Event | 2016-03-18 |
| Date Mfgr Received | 2016-04-13 |
| Date Added to Maude | 2016-04-21 |
| 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 | 2016-04-21 |
| 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 | 2016-04-21 |