MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2015-08-13 for SYNPLUG - UNKNOWN SIZE XXX-SYNPLUG manufactured by Isotis Orthobiologics, Inc.
[23358163]
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
[23358164]
Integra received an inquiry from the (b)(6) national competent authority (b)(6) regarding reports they had received from a (b)(6) hospital regarding osteolysis. The inquiry received on july 21 2015 indicated follow up for 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 patients / adverse events integra has already provided mdr's for, it will be noted in a follow-up mdr. This report is for patient 3 of the 3 patients. The narrative and details of this event have been translated from (b)(6) as follows: we herewith report to you about the outpatient examination (follow-up) of the aforementioned patient of (b)(6) 2015. Diagnoses status post total hip arthroplasty left dated (b)(6) 2005. Minimal osteolysis in the region of the cement barrier. Status post meniscectomy and di! Bridement due to medial posterior meniscus horn lesion of the right knee dated (b)(6) 2005. Progression: the scheduled clinical/ radiological progress check-up takes place around 10 years after the implantation of the left hip tp. [redacted] continues to be pain free and can walker longer distances and no longer needs to take pain medication. Findings: left hip: scar conditions without irritation. No pain on compression. Flexion / extension 100/0/0 degrees. Inner rotation / outer rotation 15/0/30 degrees. X-ray: pelvic overview and hip joint left axially dated (b)(6) 2015: in comparison to previous images normal position of the hip-tp implant. No loosening of the component. There is merely a minimal osteolysis in the region of the cement barrier. Further procedure around 10 years post hip tp left the progression continues to be very satisfactory. Accordingly, our next clinical radiological progress check-up will take place in 5 years' time. An appointment will be scheduled accordingly in writing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2090010-2015-00035 |
| MDR Report Key | 5006674 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2015-08-13 |
| Date of Report | 2015-07-21 |
| Date Mfgr Received | 2015-07-21 |
| Date Added to Maude | 2015-08-17 |
| 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 | 3 |
| Event Location | 3 |
| 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 | 0 |
| Brand Name | SYNPLUG - UNKNOWN SIZE |
| Generic Name | SYNPLUG |
| Product Code | LZN |
| Date Received | 2015-08-13 |
| Catalog Number | XXX-SYNPLUG |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ISOTIS ORTHOBIOLOGICS, INC |
| Manufacturer Address | IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-08-13 |