MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2015-08-03 for SYNPLUG - UNK SIZE XXX-SYNPLUG manufactured by Isotis Orthobiologics, Inc.
[6073553]
Integra received an inquiry from the (b)(4) regarding reports they had received from a (b)(6) hospital regarding osteolysis. The inquiry received on 07/08/2015 indicated adverse events for 3 patients had been reported to the authority. At this time, it is unclear if the information provided to integra by the authority 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 3 mdr's for these reports. Should the additional information indicate any of the 3 adverse events relate to patient/adverse events integra has already provided mdr's for, it will be noted in a follow-up mdr. This report is for patient 2 of the 3 patients. The narrative and details of this event have been translated from (b)(6) as follows: diagnose: status post total hip prosthesis implant on the right side of (b)(6) 2010 with coxarthritis on the right side; very minimal osteolyses with synplug cement block; mild coxarthritis on the left side; multiple myeloma. Progression: the planned clinical/radiological progress check-up takes place 5 years after the implantation of the hip tp. The patient is very satisfied with the results and also goes for walks and hikes regularly without feeling any pain. From time to time, there are still the known bursitis trochanteria complaints, which, however, rapidly pass again with application of ointment and mild rest. There are only mild complaints regarding the left hip. Findings: fluid gait. The pelvis is straight. Unirritated scar conditions on the right hip joint in the anterior region. Mild pain on compression over the trochanter major on the right side. No pain when shaking, no axial shock pain. No other pain on compression, no impingement pain. The range of motion is as follows in extension/flexion of the right hip: 0/0/125, outer rotation/inner rotation 45/0/35. The peripheral dms [unidentified] is intact.
Patient Sequence No: 1, Text Type: D, B5
[14232480]
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 biodegradeable 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 findings 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 | 2090010-2015-00031 |
| MDR Report Key | 4972574 |
| Report Source | 01,05,07 |
| Date Received | 2015-08-03 |
| Date of Report | 2015-07-08 |
| Date Mfgr Received | 2015-07-08 |
| Date Added to Maude | 2015-08-06 |
| 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 DR. |
| 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 - UNK SIZE |
| Generic Name | SYNPLUG |
| Product Code | LZN |
| Date Received | 2015-08-03 |
| 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. Required No Informationntervention | 2015-08-03 |