MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2016-04-07 for OPTIPLUG CEMENT RESTRICTOR 4361 manufactured by Isotis Orthobiologics, Inc.
[42144455]
Radiographs alleging the event were received. An acute 2mm abnormality near the distal tip was observed. Another larger unrelated 4-5 mm abnormality laterally about 20mm superior from distal tip was observed. It is unknown which of these are the allegation of osteolysis. There is no current plan for revision, and the patient will continue to be monitored. During the review of the dhr, it was concluded that the product was manufactured on 6/20/2012, inspected and accepted for use and met all specified parameters of the with no associated nonconformance specific to the product issue. No product will be returned as it remains implanted and no further evaluation of the product can be completed at this time. Patient activity level at the time or prior to the event is unknown. Patient's bone quality is good. It is unknown if the patient complied with post-operative care instructions. It is unknown if the concomitant device (hip prosthesis) or bone cement contributed to the event. The complaint database was reviewed and indicated there were other related complaints for osteolysis observation. 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. Device remains in-situ.
Patient Sequence No: 1, Text Type: N, H10
[42144456]
Initial hip replacement (hip arthroplasty) surgery involving a biomet stanmore hip prosthesis, thp cement, and optiplug cement restrictor occurred on (b)(6) 2012. During three year follow up, radiograph depicted osteolysis in patient right leg near the hip stem. Patient is asymptomatic, and currently there is no plan for revision. Surgeon will continue to monitor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2090010-2016-00003 |
| MDR Report Key | 5558213 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2016-04-07 |
| Date of Report | 2016-03-29 |
| Date of Event | 2015-12-22 |
| Date Mfgr Received | 2016-03-29 |
| Device Manufacturer Date | 2012-06-20 |
| Date Added to Maude | 2016-04-07 |
| 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 | 2016-04-07 |
| Catalog Number | 4361 |
| Lot Number | 200781B |
| Device Expiration Date | 2016-06-30 |
| 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. Deathisabilit | 2016-04-07 |