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.
[28146411]
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
[28146412]
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 16sep2015 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. This report is for patient 1 of the 2 patients. The narrative and details of this event have been translated from (b)(6) as follows: translation of the source document in (b)(6) language received on september 30th 2015 : diagnoses: status post total arthroplasty of the right hip on (b)(6) 2014 due to coxarthrosis, status post implantation of a total hip endoprosthesis left dated (b)(6) 2006, coronary and hypertensive heart disease , paod, arterial hypertension, chronic renal insufficiency, suspected haematuria. Progression: the patient is arriving today for the one year follow-up post total arthroplasty of the right hip. Mr [redacted] is very satisfied with the progress over the past year. He generally has no pain and subjectively he reports that he has no problems even over longer walking distances. Only on some days he has start-up problems with light pain. He carries a walking stock only due to occasional instances of dizziness. Findings right hip: scar tissue without irritation. No swelling, no reddening. No pain on palpation. Flexion/extension 120/0/0, external rotation/internal rotation 20/0/20. Abduction 30 pain on rotation, no pain on axial palpation. Left hip: flexion/extension 110/0/0 otherwise identical to opposite side. X-ray pelvic overview aligned low centrally, right hip axially dated (b)(6) 2015: right hiparthroplasty normal position. No signs of loosening. Heterotopic ossifications of the right joint capsule. The left hip arthroplasty (2006) also shows a regular position, no signs of loosening. Slight local reaction to synplug cement barrier. Further procedure we are very satisfied with the progress, 1 year postoperatively. The patient has practically no complaints. Should the currently existing slight start-up pains worsen and/or new complaints arise, we would ask the patient to contact us again. Otherwise we would schedule a regular appointment for mr [redacted] 5 years postoperatively for follow-up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2090010-2015-00041 |
| MDR Report Key | 5147437 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-10-14 |
| Date of Report | 2015-09-16 |
| Date Mfgr Received | 2015-09-16 |
| 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 |