MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-06-29 for OPTIPLUG CEMENT RESTRICTOR 804022 manufactured by Isotis Orthobiologics, Inc.
[78766009]
Report alleging the event was received (b)(6) 2017. Radiographs confirming the event were received. Immediate post operative radiographs were received and compared against event radiographs depicting serial progression of the patient. Radiographic evaluation: the cement is observed at the proximal end of the hip implant adjacent to greater trochanteric. There is no cement observed at the distal tip, which questions the use of cement and the need for the cement restrictor plug in conjunction with the use of a non- cemented/ press fit hip prosthetic. There is extensive lucency at the distal end of the prosthesis. It is unknown if there was loosening of the stem as a result of surgical site preparation or consequential osteolysis at the distal tip it is unknown which of these factors resulted in osteolysis. The most common etiologies of the radiographic findings are consistent with either infection, polyethylene debris or optiplug resorption associated osteolysis. Lot number 2007078 was inspected and accepted for use and met all specified parameters of the inspection report with no associated nonconformance specific to the product issue. No product will be returned and no further evaluation of the product can be completed at this time. There is no reported revision and 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 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
[78766010]
Initial hip replacement (hip arthroplasty) surgery involving a hip prosthesis, thp cement, and optiplug cement restrictor occurred on (b)(6) 2013. Allegedly on (b)(6) 2015 patient was presented with osteolysis near the tip hip prosthetic. Radiograph depicted the event were received (b)(6) 2017 and osteolysis was observed. Patient status post revision is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2090010-2017-00003 |
| MDR Report Key | 6678959 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2017-06-29 |
| Date of Report | 2017-05-31 |
| Date of Event | 2015-02-19 |
| Date Mfgr Received | 2017-05-31 |
| Date Added to Maude | 2017-06-29 |
| 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 | 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 | 2017-06-29 |
| Model Number | 804022 |
| Lot Number | 2007078 |
| 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 | 2017-06-29 |