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 2015-10-14 for SYNPLUG - UNKNOWN SIZE XXX-SYNPLUG manufactured by Isotis Orthobiologics, Inc.
[28245771]
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
[28245772]
Integra received an inquiry from the (b)(4) regarding reports they had received from a (b)(6) regarding osteolysis. The inquiry received on (b)(6) 2015 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) 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. This report is for patient 2 of the 2 patients. The narrative and details of this event have been translated from (b)(4) as follows: translation of the source document in (b)(4) language was received in september 30th 2015 : diagnosis: status post implant of a total arthroplasty of the right hip on (b)(6) 2014 due to coxarthrosis. Visible lysis distally of the shaft. Secondary diagnoses: status post-total prosthesis left knee (b)(4) 1993 and right knee (b)(6)1994. Tachycardic atrial fibrillation. Implantation of a vvir pacemaker on (b)(6) 2013. Cardiovascular risk factors: arterial hypertension, obesity. Osteoporosis. Chronic varicosis. Progress: this is the scheduled clinical/radiological follow-up 7 years post total arthroplasty of the right hip. The patient is very content with the right hip and has no complaints. She only complains about back pain, which is stronger in the morning, otherwise she is very content with both knee joints that she received total prostheses for and the right hip joint. Findings: right hip: scar tissue without irritation. Flexion in hip joint 100 deg, internal rotation/external rotation 30/0/40 deg, extension 0 deg, no pain on palpation. X-ray: pelvic overview and right hip axially dated (b)(6) 2015: unchanged alignment and position of the prosthetic material. Continuing visible lysis distally to the shaft, but in terms of size and extent constant to the previous check-up. Further procedure: due to very good result 7 years postoperatively, but visible lysis we will ask the patient to present herself in 2 years' time for another radiological/clinical progress check-up. The patient may contact us again at any time should she have any problems.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2090010-2015-00040 |
| MDR Report Key | 5149806 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-10-14 |
| Date of Report | 2015-09-22 |
| Date Mfgr Received | 2015-09-22 |
| Date Added to Maude | 2015-10-14 |
| 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 |
| 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 | 2015-10-14 |
| 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 | 2015-10-14 |