MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-05-29 for SYNPLUG CEMENT RESTRICTOR manufactured by Isotis Orthobiologics, Inc.
[146372469]
Summary: based on the limited radiograph provided, it appears that there are peri-prosthetic femoral and acetabular radiolucencies bilaterally that are consistent with polyethylene wear debris. Prior sequential radiographs, complete bilateral hip radiographs, and full femoral radiographs, available ct scans, full medical history, and are required for a definitive diagnosis. Assessment: the radiograph is inadequate to assess the status of either femur distal to the femoral prostheses. The femoral head components are slightly off-center bilaterally, which is consistent with wear of the polyethylene liners within the acetabular cups. There are peri-prosthetic radiolucencies adjacent to both acetabular cup components and radiolucencies surrounding the proximal cement mantels of both femora. These findings are consistent with, but not diagnostic of, osteolysis secondary to polyethylene wear debris from the acetabular cup liners. There does not appear to be significant radiolucencies at the distal femoral prostheses, but the radiograph does not include the mid- portions of the femora to evaluate these areas. No remedial action planned for left side. Surgeon will continue to monitor. 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. (b)(4). 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
[146372470]
Initial hip replacement (hip arthroplasty) surgery involving a hip prosthesis and synplug cement restrictor, left side occurred in 2006. Follow-up review (13 years) determined osteolysis distal to the tip of the prosthesis. Surgeon suggests x-rays every two years and will continue to monitor the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2090010-2019-00003 |
| MDR Report Key | 8649961 |
| Report Source | FOREIGN |
| Date Received | 2019-05-29 |
| Date of Report | 2019-05-28 |
| Date of Event | 2019-02-25 |
| Date Mfgr Received | 2019-03-27 |
| Date Added to Maude | 2019-05-29 |
| 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 AARON |
| 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 | 2019-05-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ISOTIS ORTHOBIOLOGICS, INC |
| Manufacturer Address | 2 GOODYEAR CA 96218 US 96218 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-29 |