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 2015-10-19 for SYNPLUG - UNKNOWN SIZE XXX-SYNPLUG manufactured by Isotis Orthobiologics, Inc.
[28673107]
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
[28673108]
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. Translation of source document in (b)(6) language received in (b)(4) 2015 : diagnosis: persistent enthesitis with status post implantation of a total left hip prosthesis 2004. - discrete osteolysis perifocal to the synplug cement restrictor. - exclusion of possible loosening of femoral component, by means of scintigraphic imaging dated (b)(6) 2014. - status post implantation of a total external right knee prosthesis [deleted] with: - chronic right knee pain > left, with especially pronounced right chondrocalcinosis. - chronic lumbosciatica with status post dorsal spinal fusion l2-s1. Progress: as planned, we are reviewing ms [deleted] in our consultation, now eleven years post implantation of the total left hip prosthesis. Ms [deleted] reports the same ongoing clinical findings with persisting pain symptoms in the region of the left hip and in the region of the entire left thigh. The pain predominantly occurs after long periods of mobilisation, but also on waking in the morning. There has been no observed change in symptoms over the past months and years. In terms of the chronic right knee pain, ms [deleted] has been operated on by mr [deleted]. A total knee prosthesis was implanted 6 months ago. Ms [deleted] is very satisfied with the progress in the region of the right knee and describes a marked improvement since the operation. Findings: minimally limping gait with a 1 cm clinical leg length discrepancy to the detriment of the right side. Free range of movement of the left hip with flexion/extension at 110-0-0 degrees. Internal/external rotation 40-0-20. The strong internal rotation is pain-free; the restricted external rotation is painful. No tenderness on palpation over the greater trochanter. Discrete inguinal tenderness on palpation. The patient feels definite pain symptoms both proximally and distally in the lateral, medial and anterior thigh. It remains unclear to what extent this may also be caused by a spinal problem. Diffusely, there is a marked reduction in sensation indicated in the l2 and l3 dermatome. Right knee: non-tender healed wound. Free range of movement with flexion/extension at 110-0-0 degrees. Ligamentously stable knee joint. Unremarkable examination overall, 6 months post implantation of a tkp. X-rays: pelvic and axial views of the left hip dated (b)(6) 2015: unchanged position of the hip prosthesis without signs of loosening or periprosthetic fracture. Still unchanged osteolysis perifocal to the synplug cement restrictor. There is also an eccentric abrasion of the inlay. Further procedure: ms [deleted] displays persisting chronic pain symptoms in the region of the left hip and left thigh. Radiologically we can find no evidence of a change in position or stability of the prosthesis. Ms [deleted] is extremely satisfied with the right knee joint region following implantation of a total knee prosthesis by mr [deleted]. For the eccentric abrasion of the inlay in the region of the left hip, we recommend a clinical and radiological follow-up at the clinic in 3 years time. In the event of increasing symptoms, an earlier consultation can, of course, be arranged in our clinic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2090010-2015-00043 |
| MDR Report Key | 5159717 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-10-19 |
| Date of Report | 2015-09-23 |
| Date Mfgr Received | 2015-09-23 |
| Date Added to Maude | 2015-10-19 |
| 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 | 2015-10-19 |
| 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 | 2015-10-19 |