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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Osteolysis (2377)

Event Date 02/25/2019

Event Type  Injury  

Manufacturer Narrative

Summary: based on the limited radiograph provided, it appears that there are peri-prosthetic femoral and acetabular radiolucencies bilaterally that are consistent with polyethylene wear debris.Prior sequential radiographs, complete bilateral hip radiographs, and full femoral radiographs, available ct scans, full medical history, and are required for a definitive diagnosis.Assessment: the radiograph is inadequate to assess the status of either femur distal to the femoral prostheses.The femoral head components are slightly off-center bilaterally, which is consistent with wear of the polyethylene liners within the acetabular cups.There are peri-prosthetic radiolucencies adjacent to both acetabular cup components and radiolucencies surrounding the proximal cement mantels of both femora.These findings are consistent with, but not diagnostic of, osteolysis secondary to polyethylene wear debris from the acetabular cup liners.There does not appear to be significant radiolucencies at the distal femoral prostheses, but the radiograph does not include the mid- portions of the femora to evaluate these areas.No remedial action planned for left side.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.(b)(4).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.

Event Description

Initial hip replacement (hip arthroplasty) surgery involving a hip prosthesis and synplug cement restrictor, left side occurred in 2006.Follow-up review (13 years) determined osteolysis distal to the tip of the prosthesis.Surgeon suggests x-rays every two years and will continue to monitor the patient.

• Brand Name: SYNPLUG CEMENT RESTRICTOR
• Type of Device: CEMENT OBTURATOR
• Manufacturer (Section D): ISOTIS ORTHOBIOLOGICS, INC; 2 goodyear; CA 96218
• MDR Report Key: 8649961
• MDR Text Key: 146372469
• Report Number: 2090010-2019-00003
• 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: Other
• Type of Report: Initial
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 86 YR