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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Osteolysis (2377)

Event Date 12/11/2017

Event Type  Injury  

Manufacturer Narrative

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.Though there is discrete osteolysis depicted on the radiograph, there is no evidence that osteolysis (discovered 14 years post-operatively) was caused or induced by the cement restriction plug.

Event Description

Initial hip replacement (hip arthroplasty) surgery involving a hip prosthesis, thp cement, and synplug cement restrictor, right side occurred in 2003.The left hip was revised in 2000.Allegedly during routine 14 year follow up for unrelated condition in left hip, surgeon noted eccentric abrasion on right hip and osteolysis in the distal end of the right prosthetic shaft.Patient has painless mobility in the right hip.(asymptomatic on right side).No remedial action planned for right side.Patient agrees to conservative therapeutic measure including analgesic therapy and use of a walker (rather than a cane) for the left side condition.Surgeon will continue to monitor for next two month.

• 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: 7212547
• MDR Text Key: 97989780
• Report Number: 2090010-2018-00001
• 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: 01/03/2018

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: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/03/2018
• Initial Date FDA Received: 01/23/2018
• 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: 83 YR