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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Osteolysis (2377)

Event Date 08/08/2018

Event Type  Injury  

Manufacturer Narrative

No product samples, cts, lateral radiographs, initial or serial radiographs or other medical records have been provided.Alleged osteolysis at the proximal end of the prosthetic shaft.There is osteolytic resorptive changes at the distal tip of the femoral prosthesis.A medical advisor review of the reporting surgeons 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 15 years, the synplug did not cause or contribute to the proximal loosening.

Event Description

Initial hip replacement (hip arthroplasty) surgery involving a hip prosthesis, thp cement, and synplug cement restrictor, left side occurred in 2003.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 left distal tip of the prosthetic shaft.Ct scans were not provided.No plans for revision.Surgeon will monitor.

• Brand Name: SYNPLUG CEMENT RESTRICTOR
• Type of Device: CEMENT OBTURATOR
• Manufacturer (Section D): ISOTIS ORTHOBIOLOGICS, INC; irvine CA 96218
• Manufacturer Contact: aaron ; 5770 armada drive; carlsbad, CA 92008
• MDR Report Key: 7866681
• MDR Text Key: 119929326
• Report Number: 2090010-2018-00004
• Device Sequence Number: 1
• Product Code: LZN
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: KO10840
• 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: 09/11/2018

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2018
• Initial Date FDA Received: 09/11/2018
• 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: 81 YR