MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-02-26 for SYNPLUG CEMENT RESTRICTOR manufactured by Isotis Orthobiologics, Inc.
[101000484]
No product samples, lateral radiographs, initial or serial radiographs or other medical records have been provided. Single event radiograph depicting osteolysis in the distal region of the right prosthetic was received. Medical evaluation notes no loosening and no definite fractures observed. The amount of cortical thinning is less than 10%. Symptoms due to changes at the plug site appears to be infrequent. The risk of fracture appears to be less than the literature fracture risk. Risk of progression significantly less after 2-5 years.
Patient Sequence No: 1, Text Type: N, H10
[101000485]
Initial hip replacement (hip arthroplasty) surgery involving a hip prosthesis, thp cement, and synplug cement restrictor, right side occurred in 2002. Allegedly during routine year follow up for unrelated condition of pain due to insufficient gluteal musculature (gluteus medias muscle), dd muscle tear after a stumble and fall. The surgeon noted osteolysis in the distal end of the right prosthetic shaft with signs of loosening. Surgeon recommends the patient and the husband the increase of the everyday agility to build up the muscles. Furthermore, she was prescribed topical nsaid medication. No remedial action planned for right side. Surgeon will continue to monitor and take radiological control in five years.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2090010-2018-00002 |
| MDR Report Key | 7298118 |
| Report Source | FOREIGN |
| Date Received | 2018-02-26 |
| Date of Report | 2018-02-06 |
| Date of Event | 2018-01-26 |
| Date Mfgr Received | 2018-02-06 |
| Date Added to Maude | 2018-02-26 |
| 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 | 2018-02-26 |
| 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 | 2018-02-26 |