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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Osteolysis (2377)

Event Date 01/08/2018

Event Type  Injury  

Manufacturer Narrative

No product samples, cts, lateral radiographs, initial or serial radiographs or other medical records have been provided.Single event radiograph was received and confirms osteolysis at the proximal end of the prosthetic shaft.There is osteolytic resorptive changes at the distal tip of the femoral prosthesis a medical review of the radiograph notes, cement did not extend beyond the tip of the prosthesis, cortical thinning at the distal tip is likely insignificant without further imaging to confirm.Within in medical probability, at 16 years, the synplug did not cause or contribute to the proximal loosening which per note appears to be causing the patients pain.

Event Description

Initial hip replacement (hip arthroplasty) surgery involving a hip prosthesis, thp cement, and synplug cement restrictor, right side occurred in 2002.Allegedly patient had pain in the right leg.Ct scan was reportedly performed and allegedly a fine lysis margin with pathologically metabolism formed at the proximal portion of the cemented femoral shaft with signs of loosening.The surgeon additionally noted osteolysis in the right distal tip of the prosthetic shaft.Ct scans were not provided.Plans for revision are unknown.

• 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: 7298403
• MDR Text Key: 100998672
• Report Number: 2090010-2018-00003
• 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: 02/15/2018

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: 02/15/2018
• 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: 80 YR