MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2015-09-16 for SYNPLUG - UNKNOWN SIZE XXX-SYNPLUG manufactured by Isotis Orthobiologics, Inc.
[25992758]
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
[25992759]
Integra received an inquiry from the (b)(4) regarding reports they had received from a (b)(6) hospital regarding osteolysis. The inquiry received on 18aug2015 indicated follow up for an adverse event had been reported to the authority. At this time, it is unclear if the information provided to integra by the authority regards a patient / adverse event integra has already provided an mdr's for or if this relates to a new patient / adverse event. Integra has contacted the (b)(6) hospital directly to ascertain this as well as additional information and in the interim is submitting this mdr. Should the additional information indicate the adverse event relates to patients / adverse events integra has already provided mdr's for, it will be noted in a follow-up mdr. The narrative and details of this event have been translated from german as follows: we herewith report to you about the outpatient examination (follow-up) of the aforementioned patient of (b)(6) 2015. Diagnosis status after total right hip arthroplasty on (b)(6) 2010 progression planned postoperative clinical and radiological follow-ups after 5 years. The patient is feeling good. No pains. The patient still suffers from occasional vertigo and we are clarifying this with the general practitioner. Findings smooth gait without antalgic gait. Right hip with skin and soft tissue conditions free of any irritations as well as well healed scar of the minimally invasive surgical procedure. Range of motion flexion/extension 120/0/0 degrees internal-/external rotation 20/0/40peripheral oms intact. Rest of the femur does not show pain on palpation. X-ray pelvic view and axial right position of the hip show normal position of the implant without any secondary signs of loosening. Slightly progressive lysis zone in the area of the former cement block. Further procedure excellent postoperative result after 5 years. Another follow-up 10 years after surgery birth date of the patient: 1920.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2090010-2015-00037 |
| MDR Report Key | 5082232 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-09-16 |
| Date of Report | 2015-08-18 |
| Date of Event | 2015-08-07 |
| Date Mfgr Received | 2015-08-18 |
| Date Added to Maude | 2015-09-16 |
| 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 |
| Reporter Occupation | DENTAL HYGIENIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER MARIA LEONARD |
| Manufacturer Street | 311 ENTERPRISE DRIVE 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | ISOTIS ORTHOBIOLOGICS, INC |
| Manufacturer Street | 2 GOODYEAR PLACE, SUITE A |
| Manufacturer City | IRVINE CA 96218 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 96218 |
| 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 | 2015-09-16 |
| Catalog Number | XXX-SYNPLUG |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ISOTIS ORTHOBIOLOGICS, INC |
| Manufacturer Address | 2 GOODYEAR PLACE, SUITE A 2 GOODYEAR PLACE, SUITE A IRVINE CA 96218 US 96218 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2015-09-16 |