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 2016-02-04 for SYNPLUG - UNKNOWN SIZE XXX-SYNPLUG manufactured by Isotis Orthobiologics, Inc.
[37466998]
Integra completed its internal investigation 18jan2016. The investigation included: method: review of device history records. Review of complaint management database for similar complaints. Results: the synplug product size and lot number (most likely) will not be provided given the information in the complaint (implanted product some time ago), therefore, it is not possible to conduct a dhr review for potential anomalies that might be associated with the alleged complaint. The complaint database was reviewed for the last two years and indicated there were other related complaints for osteolysis observation. Conclusion: 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
[37466999]
Issue with synplug. Date of clinic follow up letter: (b)(6) 2015. (b)(6). Diagnoses: status post 10 years total arthroplasty implant right - discrete syn-plug reaction distally from the tip of the prosthesis. Bilateral gonarthrosis. Progression: the patient is very content and has no complaints relating to the right hip. Under load (extended walks, ski tours! ) the patient reports strain related pain in both knee joints, right with medial emphasis. The patient does not take any analgesics. Findings: fluid gait without limping. Pain free movement of both hip joints without restrictions. Extension deficit in both knee joints of 5?. Bow legs on both sides with clinical signs of degenerative changes in terms of a gonarthrosis. Flexion in both knee joints very good up to 125?. X-ray: pelvic overview and right hip joint axially: firm position of the total hip arthroplasty discrete reaction distally from the tip of the prosthesis without noteworthy thinning of the cortical bone shaft. Further procedure: normal progress as far as the right hip is concerned. The patient is free of discomfort with regard to the hip joint. The knee problems as far as the gonarthrosis is concerned, are not so pronounced that there is a need for action. However, in case of increasing discomfort, non-steroidal anti-inflammatory agents can be used in any case, in case of activation an infiltration may provide further relief. The syn plug changes in the shaft region are discrete, problems are not expected. Next follow-up appointment of the patient in 5 years with x-ray. In case of discomfort patient may contact us at any time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2090010-2016-00001 |
| MDR Report Key | 5410002 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-02-04 |
| Date of Report | 2016-01-05 |
| Date of Event | 2015-12-17 |
| Date Mfgr Received | 2016-01-26 |
| Date Added to Maude | 2016-02-04 |
| 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 |
| 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 | 2016-02-04 |
| 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. Other | 2016-02-04 |