MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-01-23 for SYNPLUG CEMENT RESTRICTOR manufactured by Isotis Orthobiologics, Inc.
[97989780]
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. Though there is discrete osteolysis depicted on the radiograph, there is no evidence that osteolysis (discovered 14 years post-operatively) was caused or induced by the cement restriction plug.
Patient Sequence No: 1, Text Type: N, H10
[97989781]
Initial hip replacement (hip arthroplasty) surgery involving a hip prosthesis, thp cement, and synplug cement restrictor, right side occurred in 2003. The left hip was revised in 2000. Allegedly during routine 14 year follow up for unrelated condition in left hip, surgeon noted eccentric abrasion on right hip and osteolysis in the distal end of the right prosthetic shaft. Patient has painless mobility in the right hip. (asymptomatic on right side). No remedial action planned for right side. Patient agrees to conservative therapeutic measure including analgesic therapy and use of a walker (rather than a cane) for the left side condition. Surgeon will continue to monitor for next two month.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2090010-2018-00001 |
| MDR Report Key | 7212547 |
| Report Source | FOREIGN |
| Date Received | 2018-01-23 |
| Date of Report | 2018-01-03 |
| Date of Event | 2017-12-11 |
| Date Mfgr Received | 2018-01-03 |
| Date Added to Maude | 2018-01-23 |
| 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 | 2018-01-23 |
| 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 | 2018-01-23 |