MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-13 for SYNPLUG - UNK SIZE XXX-SYNPLUG manufactured by Isotis Orthobiologics, Inc.
[23382372]
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 that 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
[23382373]
Integra received an inquiry for the (b)(6) regarding reports they had received from a (b)(6) regarding osteolysis. The injury received pm (b)(6) 2015 indicated follow up for 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 (b)(6)l 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 2 of the 3 patients. The narrative and details of this event have been translated from (b)(4) as follows: we herewith report to you about the outpatient examination (follow-up) of the aforementioned patient of (b)(6) 2015. Diagnosis: status post left hip tp 2005. Status post right hip tp 1989 (b)64). Secondary diagnoses: arterial hypertension; status post forefoot infection with abscessed soft tissue (b)(6) 2014; rheumatoid arthritis; impaired gait; multiple thyroid nodules, atrial fibrillation under marcumar, lumbar ischialgia; osteoporosis; depressive episodes; renal insufficiency. Progression: scheduled clinical/radiological progress check-up of the patient with status post bilateral hip tp implantation. Mrs [redacted] has absolutely no complaints about her hips and can manage to walk even longer distances without problems. No pain medication needs to be administered. Further procedure. Around 10 and/or 26 years post hip tp on both sides the progression continues to be normal. There is merely radiological evidence for a minimal osteolysis in the region of the cement barrier on the left. As the patient has no complaints we will take a pragmatic approach and not undertake any further follow-up consultations. The patient will contact us should any problems arise.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2090010-2015-00034 |
| MDR Report Key | 5006676 |
| Date Received | 2015-08-13 |
| Date of Report | 2015-07-21 |
| Date Mfgr Received | 2015-07-21 |
| Date Added to Maude | 2015-08-17 |
| 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 | 3 |
| Event Location | 3 |
| 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 | 0 |
| Brand Name | SYNPLUG - UNK SIZE |
| Generic Name | SYNPLUG |
| Product Code | LZN |
| Date Received | 2015-08-13 |
| 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 96218 US 96218 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-08-13 |