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.
[28140185]
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
[28140186]
Integra received an inquiry from the (b)(6) regarding reports they had received from a (b)(6) hospital regarding osteolysis. The inquiry received on (b)(4) 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) 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: pain in the region of the attachment point of the tensor fasciae latae muscle with: status post left hip arthroplasty dated (b)(6) 2003 (dr. (b)(6)) and with: secondary dislocated medial femoral neck fracture post screw osteosynthesis dated (b)(6) 2003. Secondary diagnoses: multiple myeloma lgg kappa (initial diagnosis 2005). Currently: raised paraprotein lgg (new course of chemotherapy) status post bullous variant of sweet's syndrome 2008. Coronary heart disease and generalised macroangiopathy; status post bilateral pulmonary embolism; chronic renal insufficiency; autoimmune polyglandular syndrome type 3; progress: [redacted] is arriving today for the scheduled follow-up visit 2 years after the previous check-up. The pain that [redacted reported in 2013, (10 years postoperatively), have subjectively improved. He report that he has no problems to travel on foot for 5 hours. The known pain in the region of the attachment point of the tensor fascie latae muscle occurs on some days only and can be independently eliminated by light mobilisation exercises. Findings: gait without limping. Level pelvis. No inflammation of the soft tissue. No reddening, no swelling, no hyperthermia in the region of the surgery area on the hip. No pain on compression. Flexion/extension 120/0/0 degrees, internal/external rotation 0/0/30 degrees, abduction/adduction 50/0/10 degrees. X-ray: pelvic overview and left hip axially: normal position of the prosthesis. No evidence for loosening. Regional reaction of the bone to synplug cement barrier, distal to the prosthesis shaft. This is unchanged in comparison with the image dated 2013. Further procedure: since the pain symptoms of the patient have improved since 2013, there is no indication, as far as we are concerned, to indicate further measures. We recommend to the patient to use a walking stick for long distances. The osteolyses perifocal to the cement barrier need ongoing monitoring. Next check-up with x-ray in two years' time with [redacted]during regular consulting hours. Should the pain increase, we would ask that the patient contacts us again.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2090010-2015-00039 |
| MDR Report Key | 5147122 |
| 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 |