MAUDE Adverse Event Report: ISOTIS ORTHOBIOLOGICS, INC SYNPLUG CEMENT RESTRICTOR; CEMENT OBTURATOR

Device Problems Failure to Osseointegrate (1863); Patient-Device Incompatibility (2682)

Patient Problem Osteolysis (2377)

Event Date 03/18/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Event could not be confirmed.No radiographs were received.No product will be returned as it remains implanted, no product information was given and no further evaluation of the product can be completed at this time.Patient is asymptomatic.There is no current plan for revision, and the patient will continue to be monitored.Patient activity level is high.Patient's bone quality is unknown.It is unknown if the patient complied with post-operative care instructions.It is unknown if the concomitant device (hip prosthesis) or bone cement contributed to the event.The complaint database was reviewed and indicated there were other related complaints for osteolysis observation.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.Device remains in-situ.

Event Description

Patient came for 10-year-check as planned.Patient had hip transplant right (shaft weber ss, acetabulum firmore 56mm, inlay durasul 36).He is very satisfied with the development.He is without any discomfort on both hips and can do all things he wants to do.Surgeon evaluation: scar without irritation.Fluid walking pattern.Mobility of right hip flexion/extension 120/0/0°, inner rotation/outer rotation 10/0/20°, abduction/ adduction 60/0/45°.Mobility without pain of left hip joint.Small distal osteolysis, distal of shaft of femur.Surgeon's radiological evaluation: regular placement of hip transplant without any sign of loosening or implant failure.Small osteolysis distal of femur shaft.(radiograph was not provided for investigation) patient outcome: the progress is excellent after a total hip prosthesis implantation on the right.Patient is asymptomatic, and currently there is no plan for revision.Surgeon recommend the next check with x-ray in 5 years, i.E.15 years after hip transplant implantation.Surgeon will continue to monitor.

• Brand Name: SYNPLUG CEMENT RESTRICTOR
• Type of Device: CEMENT OBTURATOR
• Manufacturer (Section D): ISOTIS ORTHOBIOLOGICS, INC; irvine CA 96218
• Manufacturer Contact: peter perhach ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165681
• MDR Report Key: 5596202
• MDR Text Key: 43288315
• Report Number: 2090010-2016-00004
• Device Sequence Number: 1
• Product Code: LZN
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K010840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR