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.
[28138587]
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
[28138588]
Integra received an inquiry from the (b)(6) regarding reports they had received from a swiss 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 swiss 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 2 of the 2 patients. The narrative and details of this event have been translated from german as follows: translation of source document in (b)(4) language received on september 30th 2015: diagnoses: tatus post total arthroplasty left hip due to coxarthrosis on (b)(6) 2009; tatus post total arthroplasty right hip dated (b)(6) 2005; secondary diagnoses: tatus post distal radius fracture right (b)(6) 20126 tatus post complex foot injury left (b)(6) 2012; coronary and hypertensive heart disease; arterial hypertension. Progression: we carried out the scheduled radiological/clinical follow-up 10 and/or 5 years postoperatively for the aforementioned hip prostheses. The patient is very satisfied, she only has pain sensations when the weather changes. The patient regularly goes for walks with walking sticks. Findings: gat with small steps and without limping. Flexion 120?. , extension 0?. External rotation/internal rotation right 20/0/10? , external rotation/internal rotation left 30/0/10?. No inflammation of the scar tissue. X-ray: pelvic overview aligned low centrally , right hip axially dated (b)(6) 2015: regular position of the prosthetic material only with osteolyses at synplug, otherwise no evidence for loosening. Further procedure due to the very good postoperative progress and satisfied patient we will conclude our follow-up. Should the patient have any new complaints she may contact us again at any time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2090010-2015-00042 |
| MDR Report Key | 5147159 |
| 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 |