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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Osteolysis (2377)

Event Date 01/26/2018

Event Type  Injury  

Manufacturer Narrative

No product samples, lateral radiographs, initial or serial radiographs or other medical records have been provided.Single event radiograph depicting osteolysis in the distal region of the right prosthetic was received.Medical evaluation notes no loosening and no definite fractures observed.The amount of cortical thinning is less than 10%.Symptoms due to changes at the plug site appears to be infrequent.The risk of fracture appears to be less than the literature fracture risk.Risk of progression significantly less after 2-5 years.

Event Description

Initial hip replacement (hip arthroplasty) surgery involving a hip prosthesis, thp cement, and synplug cement restrictor, right side occurred in 2002.Allegedly during routine year follow up for unrelated condition of pain due to insufficient gluteal musculature (gluteus medias muscle), dd muscle tear after a stumble and fall.The surgeon noted osteolysis in the distal end of the right prosthetic shaft with signs of loosening.Surgeon recommends the patient and the husband the increase of the everyday agility to build up the muscles.Furthermore, she was prescribed topical nsaid medication.No remedial action planned for right side.Surgeon will continue to monitor and take radiological control in five years.

• 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: 7298118
• MDR Text Key: 101000484
• Report Number: 2090010-2018-00002
• 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: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• 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
• Date Manufacturer Received: 02/06/2018
• 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: 88 YR