MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2016-12-21 for OPTIPLUG CEMENT RESTRICTOR manufactured by Isotis Orthobiologics, Inc.
[63055825]
Report alleging the event was received from (b)(6) on 12/7/2016. Radiographs were noted to be enclosed to (b)(6). After requests to (b)(6) and to the doctor, no radiographs confirming the event were received. No medical evaluation could be performed. It is unknown if there are allegations of osteolysis. The complaint of peri-prosthetic fracture can not be confirmed. There is a current plan for revision, but the patient status is unknown. Patient activity level at the time or prior to the event is unknown. Patient's bone quality is unknown. It is unknown if the patient complied with post-operative care instructions or sustained a fall/impact of some sort. It is unknown if the concomitant device (hip prosthesis) or bone cement contributed to the event. 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.
Patient Sequence No: 1, Text Type: N, H10
[63055826]
Initial hip replacement (hip arthroplasty) surgery involving a hip prosthesis, thp cement, and optiplug cement restrictor occurred on (b)(6) 2012. Allegedly on (b)(6) 2016 patient incurred a peri-prothesis fracture near the hip prosthetic. (b)(6), references a radiograph depicted a fracture but radiographs were not forwarded on to manufacturer. The fracture resulted in a need for medical intervention/revision. Patient status post revision is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2090010-2016-00008 |
| MDR Report Key | 6197245 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2016-12-21 |
| Date of Report | 2016-12-07 |
| Date of Event | 2016-07-02 |
| Date Mfgr Received | 2016-12-07 |
| Date Added to Maude | 2016-12-21 |
| 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 | OPTIPLUG CEMENT RESTRICTOR |
| Generic Name | CEMENT OBTURATOR |
| Product Code | LZN |
| Date Received | 2016-12-21 |
| 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 | 1. Required No Informationntervention | 2016-12-21 |