MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-11-19 for SYNPLUG CEMENT RESTRICTOR manufactured by Isotis Orthobiologics, Inc.
[127851116]
Radiographs were provided for review images received did not detect osteolysis at the proximal end of the prosthetic shaft. A medical review of the radiograph notes, what is noted as osteolysis is most likely radio residual cement plug. If anything the femoral cortical bin looks almost normal. Less than normal cement distal to femoral stem. The plug would not play a significant role in the fracture. Looks like the fracture occurred proximal to the plug, at the end of the cement mantel. Root cause analysis: within in medical probability, at 11 years, the synplug did not cause or contribute to the femur fracture, left. Though the 11 year post-operative event was alleged to involve synplug, 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. A risk/benefit analysis of two reported fractured, 58 reported osteolysis without the need for medical intervention and 100,000+ patients benefiting from a successful surgery it can be concluded that the benefit outweighs the risk. 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
[127851117]
Initial hip replacement (hip arthroplasty) surgery involving a hip prosthesis, with weber straight shaft ss, fitmore cup size 52, durasul inlay size 32, cobalt chrome head size 32 medium, palacos cement, synplug cement restrictor size 1, left side occurred (b)(6) 2007. A fracture on left side required surgery on (b)(6) 2018. Surgery consisted of open, reposition and compound osteosynthesis of left femur with palacos cement and ncb plate, left femur, on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2090010-2018-00005 |
| MDR Report Key | 8087218 |
| Report Source | FOREIGN |
| Date Received | 2018-11-19 |
| Date of Report | 2018-11-19 |
| Date of Event | 2018-08-01 |
| Date Mfgr Received | 2018-10-20 |
| Date Added to Maude | 2018-11-19 |
| 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 |
| Manufacturer Street | 5770 ARMADA DRIVE |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| 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 |
| Product Code | LZN |
| Date Received | 2018-11-19 |
| 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 | IRVINE CA 96218 US 96218 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-11-19 |