MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07,08 report with the FDA on 2015-07-14 for SYNPLUG -UNKNOWN SIZE XXX-SYNPLUG manufactured by Isotis Orthobiologics, Inc.
[6049552]
Integra received an inquiry from (b)(6) regarding reports they had received from a (b)(6)hospital regarding loosening of hip arthroplasty femoral components and osteolysis. The inquiry indicated adverse events for 22 patients had been reported to (b)(6). At this time, it is unclear if the information provided to integra by (b)(6) regards patients / adverse events integra has already provided mdr's for or if they relate to new patients / adverse events. Integra has contacted the (b)(6) hospital directly to ascertain this as well as additional information and in the interim is submitting 22 mdr's for these reports. Should the additional information indicate any of the 22 adverse events relate to patients / adverse events integra has already provided mdr's for, it will be noted in a follow-up mdr. This report is for patient 7 of the 22 patients. The narrative and details of this event have been translated from (b)(6) as follows: synplug and aseptic loosening of the femoral component "we have provided you with a list of patients, who have suffered aseptic loosening of the femoral component and extensive osteolysis; osteolysis with a thinning of the corticalis. General additional information provided: the osteolysis cases were first discovered at the 1 year monitoring visits. Initially, little attention was paid to these phenomena. Many osteolysis (incidents) were only visible in appropriate radiological x-ray investigations. The osteolysis became more apparent subsequently at the 5-year monitoring visit. Of the 22 patients reported for this event, revision surgery was carried out in all patients with aseptic loosening of the femoral component and in some it was possible to carry out a histological analysis of the bone perifocal to the synplug cement barriers. X-ray images are available for the 22 patients that have been affected.
Patient Sequence No: 1, Text Type: D, B5
[13975526]
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 and 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
| Report Number | 2090010-2015-00014 |
| MDR Report Key | 4917848 |
| Report Source | 01,06,07,08 |
| Date Received | 2015-07-14 |
| Date of Report | 2015-06-15 |
| Date Mfgr Received | 2015-06-15 |
| Date Added to Maude | 2015-07-17 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARIA LEONARD |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNPLUG -UNKNOWN SIZE |
| Generic Name | SYNPLUG |
| Product Code | LZN |
| Date Received | 2015-07-14 |
| Catalog Number | XXX-SYNPLUG |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Other | 2015-07-14 |