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.
[23382380]
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 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 same 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
[23382381]
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)(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) 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 patients i 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)(6) as follows: we herewith report to you about the outpatient examination (follow-up) of the aforementioned patient of (b)(6) 2015. The patient is presenting for the scheduled clinical aseptic loosening of the femoral component of the left hip tp: diagnoses: aseptic loosening of the femoral component of the left hip tp; status post primary total hip endoprosthesis 0212004; status post left hip tp change on (b)(6) 2005; status post shaft-head-inlay-change left hip via extended trochanteric osteotomy and biopsy on (b)(6) 2014; status post right hip tp on (b)(6) 2011. Secondary diagnoses: type ll diabetes mellitus, initial diagnosis 0112015; hyperthyreosis, initial diagnosis 0112015; accentuated large intestinal wall of descending colon and sigma (6mm - abdominal ct; (b)(6) 2014: thickened wall in descending colon without evidence for a diverticulitis, differential diagnosis colitis. Clinically suspected intermittent claudication with: missing foot pulses; nicotine abuse 50py, suspended 1. 5 years ago. Copd gold 2 (b). Arterial hypertension. Status post anterior shoulder dislocation right treated conservatively 0212014. Progression: the patient is presenting for the scheduled clinical follow-up 2 weeks post hip infiltration left and for discussion of the further procedure post spect-examination, [redacted] reports that she had been free of pain for one day after the infiltration, then the pain restarted as before. 2 weeks ago an analgesic therapy was started. Since then symptoms have improved slightly. The patient can walk for 0. 5 - 1. 5 hours per day. She complains about permanent pain in the region of the trochanter and in the area of the buttocks with fluctuating intensity. However, the absence of strength on the left hand side is the dominant impairment for the patient. Findings: insecure, slightly limping gait, slight valgus of leg axis. Left hip: scar conditions without irritation, no pain on compression, flexion i extension 1101010 a, inner rotation i outer rotation 1010120 a. The patient is not able to hold the raised stretched leg against gravity. Strength grade m3/5. Right hip: scar condition dry and without irritation, flexion i extension: 110/0/0 degrees, inner rotation i outer rotation 20/0/10 degrees. Peripheral oms intact. X-ray: see attached report spect-ct. Further procedure: the most recent left hand hip joint infiltration has brought practically no benefit for the patient. The spect-ct examination shows in comparison to the previous investigation in (b)(6) 2014 a discrete increase of the lysis margin and the proximal third of the prosthesis shaft in the region of the right hip. Also evident is a discrete activity increase around the tip of the prosthesis. The distal osteolysis appears approximately constant compared to the previous results by conventional radiology, i. E. Based on the current problems with relatively good compensation of the established analgesic therapy we currently see no indication for surgery. Further annual follow-up visits are planned. An appointment will be arranged with the patient in writing. It was recommended to the patient to continue to remain physically active. At most a stick should be used to support the right hand side should the problems worsen. No xrays were provided to integra for this case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2090010-2015-00033 |
| MDR Report Key | 5006667 |
| 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 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-08-13 |