MAUDE Adverse Event Report: ISOTIS ORTHOBIOLOGICS INC. OPTIPLUG CEMENT RESTRICTOR; CEMENT OBTURATOR

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Osteolysis (2377)

Event Date 05/18/2019

Event Type  Injury  

Manufacturer Narrative

No product samples, cts, lateral radiographs, initial or serial radiographs or other medical records have been provided.Distribution ceased in december 2013.Germany, europe and worldwide sales for the past six years is zero.Risk management review: risk management files for the product have been updated to include the originally unidentified risk regarding the occurrence of osteolysis in some patients implanted with the biodegradable cement restrictors.Additionally, a risk benefit analysis was completed in may 2014 that concluded the overall medical benefits of the synplug products may not outweigh individual residual risk of osteolysis, primarily due to the lack of osteolysis reports for other cement restrictor types and options available to surgeon.Based on all available data at that time, no causal relationship between the use of the products and the reported instances of osteolysis could be demonstrated.Surgeon will continue to monitor.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.A risk/benefit analysis of two reported fractured, 55 reported osteolysis without the need for medical intervention and 100,000+ patients benefiting from a successful surgery it can be concluded that the benefit outweighs the risk.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.Root cause is unknown.

Event Description

Initial surgery is unknown for use of the cement restrictor optiplug.Incident received by 3rd party.According to the received incident form it was discovered local osteolysis in the femoral shaft with thinning of the cortex and insufficiency fracture within the framework of a minor trauma.No plans for revision were described.Sales ceased on this product in 2013, making index surgery well over six years ago.

• Brand Name: OPTIPLUG CEMENT RESTRICTOR
• Type of Device: CEMENT OBTURATOR
• Manufacturer (Section D): ISOTIS ORTHOBIOLOGICS INC.; 2 goodyear; 96218
• MDR Report Key: 8858056
• MDR Text Key: 153703000
• Report Number: 2090010-2019-00004
• Device Sequence Number: 1
• Product Code: LZN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1