MAUDE Adverse Event Report: ISOTIS ORTHOBIOOGICS SYNPLUG CEMENT RESTRICTOR; CEMENT OBTURATOR

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Osteolysis (2377)

Event Date 11/30/2018

Event Type  Injury  

Manufacturer Narrative

No remedial action planned for right side.Medical evaluation of received radiograph notes no loosening and no definite fractures observed.According to the medical report received the osteolysis in the radiological control is stationary, patient is without pain and the surgeon has elected to proceed with 2-year follow-ups.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.

Event Description

Initial hip replacement (hip arthroplasty) surgery involving a hip prosthesis, thp cement, and synplug cement restrictor, right side occurred in 2007.Planned clinical / radiographic follow-up 11 years postoperatively observed stationary osteolysis in the distal region of the right prosthetic.Device remains in the patient.No remedial action planned.Surgeon will continue to monitor every two-years.The patient reports that she was fine, that she is free of complaints.She could walk for two hours daily without any problems and is not restricted at all in everyday life.

• Brand Name: SYNPLUG CEMENT RESTRICTOR
• Type of Device: CEMENT OBTURATOR
• Manufacturer (Section D): ISOTIS ORTHOBIOOGICS; irvine CA 96218
• Manufacturer Contact: aaron ; 2 goodyear; irvine, CA 92618
• MDR Report Key: 8423116
• MDR Text Key: 138893851
• Report Number: 2090010-2019-00001
• 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: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2019
• 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