MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2015-08-03 for SYNPLUG - UNKNOWN SIZE XXX-SYNPLUG manufactured by Isotis Orthobiologics, Inc.
[16499704]
Integra received an inquiry from the (b)(4) regarding reports they had received from a (b)(6) hospital regarding osteolysis. The inquiry received on 07/08/2015 indicated 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 swiss 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 patient/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: diagnoses: status post total hip prosthesis implant on the left side of (b)(6) 2010 and total hip prosthesis implant on the right side of (b)(6) 2010. Discrete osteolyses with synplug cement blocks progression. The planned 5-year progress check-up takes place after implantation. The patient is very satisfied with the two prostheses, and is particularly free of pain. She is mobile with a cane for safety when she is out of the house. She does not use a cane for shorter distances and at home. Findings: fluid gait, event without a cane. Known obesity. Unirritated wound conditions bilaterally. Painless mobility in both hip joints with extension/flexion bilaterally 0/0/110, outer rotation/inner rotation 30/0/25. No pain when shaken and no axial shock pain. X-ray: pelvic overview and hip joints bilaterally, axially: normal position of the prostheses on both sides without signs of loosening. Compared to the previous examination of (b)(6) 2011, progredient discrete lysis signs distally from the distal prosthesis shaft on both sides, right greater than left. Further procedure: no information.
Patient Sequence No: 1, Text Type: D, B5
[16820232]
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 biodegradeable 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 findings 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
| Report Number | 2090010-2015-00032 |
| MDR Report Key | 4972552 |
| Report Source | 01,05,07 |
| Date Received | 2015-08-03 |
| Date of Report | 2015-07-08 |
| Date Mfgr Received | 2015-07-08 |
| Date Added to Maude | 2015-08-06 |
| 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 | 0 |
| Event Location | 0 |
| 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 | 3 |
| Brand Name | SYNPLUG - UNKNOWN SIZE |
| Generic Name | SYNPLUG |
| Product Code | LZN |
| Date Received | 2015-08-03 |
| Catalog Number | XXX-SYNPLUG |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Required No Informationntervention | 2015-08-03 |