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

Model Number 804018

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Osteolysis (2377)

Event Date 09/27/2018

Event Type  Injury  

Manufacturer Narrative

Product is absorbed, so no samples can be provided.Risk management files for the product have been updated to include the originally unidentified risk regarding the occurrence of osteolysis in some patients implanted with the biodegradable cement restrictors.Additionally, a risk benefit analysis was completed in may 2014 that concluded the overall medical benefits of the synplug products may not outweigh individual residual risk of osteolysis, primarily due to the lack of osteolysis reports for other cement restrictor types and options available to surgeon.Based on all available data at that time, no causal relationship between the use of the products and the reported instances of osteolysis could be demonstrated.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.A risk/benefit analysis of two reported fractured, 63 reported osteolysis without the need for medical intervention and 100,000+ patients benefiting from a successful surgery it can be concluded that the benefit outweighs the risk.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.Root cause is unknown.

Event Description

Initial hip replacement (hip arthroplasty) surgery involving a hip prosthesis and alleged synplug cement restrictor, left side occurred in 2012.Follow-up review (7 years) determined osteolysis distal to the tip of the prosthesis.Revision surgery occurred in summer 2018 to replace the shaft on the left side.The product was absorbed and will not be returning for evaluation.

• Type of Device: CEMENT OBTURATOR
• Manufacturer (Section D): ISOTIS ORTHOBIOLOGICS, INC; 2 goodyear
• MDR Report Key: 8984780
• MDR Text Key: 161922793
• Report Number: 2090010-2019-00006
• 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: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 804018
• Device Lot Number: 112.76
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 84 YR