MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07,company representati report with the FDA on 2015-08-03 for SYNPLUG - UNK SIZE XXX-SYNPLUG manufactured by Isotis Orthobiologics, Inc.
[22489532]
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 casual relationship between synplug & optiplug biodegradable cement restrictors or the materials they are manufactured with, and periprosthetic osteolysis (or fractures that 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 undesireable; 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
[22489533]
Integra rec'd an inquiry from (b)(6) regarding reports they had rec'd from a (b)(6) regarding osteolysis. The inquiry rec'd on (b)(6) 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 (b)(6) 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 the 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 3 patients. The narrative and details of this event have been translated from (b)(4) as follows: diagnoses: extensive osteolysis of the femoral shaft on the right side with status post implantation of a total hip prosthesis in 2005 (synplug problem); status post prosthetic treatment in 2005. Progression: a radiological progress check-up not showed osteolysis in the distal shaft region. Findings: fluid gait with definitive favouring limp on the right side. Uses a cane on the left side. Known changes in the entire lower extremity on the right side with known congenital angiodysplasia. Under strain, the patient reports pain in the central thigh on the dorsal side. Mobility in the hip joint is pain-free. End phase pain in the thigh with inflected inner rotation. X-ray: computer tomographic images which [redacted] brought along: thinning osteolysis with thinning of the shaft corticalis distally from the prosthesis shaft, perifocally, particularly in the direction of the linea aspera. Further procedure: the complaints, which the patient describes in the central thigh under strain, are certainly explainable by the existing osteolyses. For this reason, the patient is also using a cane on her left side. While these complaints do not seem to bother the patient too severely, the osteolysis is so far advanced that a periprosthetic fracture could certainly occur if a fall were to occur. Therefore, i have to advise the patient advanced protective osteosynthesis performed on the femur. This should be done using a periprosthetic ncb special implant. The patient receives anticoagulation and would have to be bridged before a surgical intervention. Due to the congenital angiodysplasia on the right leg (elephantiasis-like deformities of the entire right leg), i would also present the patient to the vascular surgery colleagues in this regard. There are angiographic report from the year 2005. Depending on the findings, i would implement the protective osteosynthesis in the presence of the vascular surgery colleagues.
Patient Sequence No: 1, Text Type: D, B5
[33010572]
Additional information received on august 26th 2015 : the information are in german language. The translation is in progress. Translation of the documents received on august 26th 2015 : surgery 1. Excision of bone defect right femur. 2. Femoral osteotomy (lifting of the bone lid with periosteal flap). 3. Filling of the osteolysis defect with bone cement. 4. Prophylactic femoral osteosynthesis due to threat of periacetabular fracture. Diagnosis predetermined point of fracture status post implantation of a total arthroplasty of the right hip 10 years ago. - angiodysplasia. Indication: increasing pain mid femur in status post implantation of a total arthroplasty of the right hip radiologically there is evidence for extensive osteolysis about the distal prosthesis shaft. Due to the radiological progression [of] the osteolyses to the synplug[? ] alterations, just as we have previously observed in other patients (to a lesser degree). Due to the symptoms and the threat of pathological fracture we state that the prophylactic osteosynthesis is indicated. The material is assessed histologically. Surgery: patient in left lateral position. Intubation anaesthesia. Skin disinfection and sterile draping of the surgery area. Lateral access to the right femur. Dr florian dick, vascular surgeon, is present due to the angiodysplasia. Subvastus access to the femur. There is no excessive bleeding, neither subcutaneously nor subfascially. The lateral intermuscular septum perforating branches are ligated. Lifting of the bone lid with periosteal flap from distal to medial of the prosthesis shaft. The osteolysis located underneath was excised in toto. A connective tissue membrane is found perifocal of the osteolysis. Once again synplug cement interface residues are found in the osteolytic material. Corticalis fragments are also sent for histological assessment. Irrigation. Fitting of a 12-hole, 4. 5 lc-dcp plate from lateral. This has 5 screws inserted proximally and distally. Cement filling of defect. Reposition of the bone lid in an anatomical position. Tightening of the plate complete with screws. The compound osteosynthesis is complete. Irrigation. Re-fixation of the vastus muscles. Subfascial redon (wound drain). Continuous suture of the fascia lata. Subcutaneous redon (wound drain). Above this wound closure with secondary suture. Skin closure with skin clips. Compression bandage. Further procedure: wound monitoring. Clip removal 14 days postoperatively. Immediate mobilisation with sticks; with initial partial load-bearing over the first 2-3 weeks. Followed by increasing full load-bearing. Use of stick 6 weeks. Radiological check-up before discharge and 8 weeks postoperatively in an outpatient appointment with me. Interim follow-up with the primary care physician
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2090010-2015-00030 |
| MDR Report Key | 4972573 |
| Report Source | 01,05,07,COMPANY REPRESENTATI |
| Date Received | 2015-08-03 |
| Date of Report | 2015-07-08 |
| Date Mfgr Received | 2015-08-26 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER MARIA LEONARD |
| Manufacturer Street | 311 ENTERPRISE DRIVE 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 - UNK SIZE |
| Generic Name | SYN PLUG |
| 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 |