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

Model Number 00000804020

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Osteolysis (2377)

Event Date 09/30/2020

Event Type  malfunction  

Manufacturer Narrative

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 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 is 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, 57 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.

Event Description

Report received noting osteolysis in (b)(6)-year old male patient, 10 years after index surgery.Osteolysis is noted in the area of the synplug via radiography.No loosening of prosthesis has been noted.No actions have been taken regarding the radiographic notation of osteolysis; prosthetic device remains implanted.No actions anticipated for an additional five years.

• Brand Name: SYNPLUG CEMENT RESTRICTOR
• Type of Device: CEMENT OBTURATOR
• Manufacturer (Section D): ISOTIS ORTHOBIOLOGICS INC.; 2 goodyear, suite a; irvine CA 92618
• Manufacturer (Section G): ISOTIS ORTHOBIOLOGICS INC.; 2 goodyear, suite a; irvine CA 92618
• Manufacturer Contact: audrey mudderman ; 5770 armada drive; carlsbad, CA 92008 ; 7602165137
• MDR Report Key: 10898206
• MDR Text Key: 220994182
• Report Number: 3001503333-2020-00001
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00000804020
• Device Lot Number: 200.288/B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2020
• 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: 68 YR