MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2016-02-12 for SYNPLUG - UNKNOWN SIZE XXX-SYNPLUG manufactured by Isotis Orthobiologics, Inc.
[38208468]
Integra completed its internal investigation 25jan2016. 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
[38208469]
It was reported postoperative osteolysis was identified for this patient. Translation received on 26 january 2016: diagnosis, status post change of total hip arthroplasty right dated (b)(6) 2014, status post total hip arthroplasty left (syn plug osteolysis prosthesis tip), progression. Patient presented as scheduled for the 1 -year follow-up with us he reported about a significant improvement of the initial pain symptoms. Currently he sensed only a certain tiredness of the two legs he reported to be slightly restricted, only because of this weakness, with a walking distance from 1-2h. Otherwise the patient is extremely content and no longer restricted by pain symptoms findings fluid gait without limping. Even leg lengths. Pain free movement in the right hip joint with flexion/extension 120-0-0? Internal rotation/external rotation 10-0-30?. The surgery scar has healed without irritation. X-ray pelvic overview and right hip axially: former osteotomy area right completely built up with bone. Position of the total hip arthroplasty as before without signs of loosening. Syn plug osteolysis distally from the prosthesis shaft after total hip arthroplasty left. Further procedure we are seeing a most pleasing progress in patient. Overall he is very content. The next follow-up appointment is planned for 5 years postoperative. Continued clinical and radiological monitoring of the syn plug osteolyses of the left prosthesis shaft.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2090010-2016-00002 |
| MDR Report Key | 5434919 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2016-02-12 |
| Date of Report | 2016-01-18 |
| Date of Event | 2014-11-20 |
| Date Mfgr Received | 2016-01-18 |
| Date Added to Maude | 2016-02-12 |
| 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 B |
| 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 | 2016-02-12 |
| 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 | 2016-02-12 |