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

Model Number 804018

Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problem Osteolysis (2377)

Event Type  malfunction  

Manufacturer Narrative

The product has been absorbed, therefore no sample can be provided for testing or analysis.The patient will continue to be monitored by their healthcare provider for any indications that would necessitate intervention.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 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.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

Osteolysis in the area of the synplug was observed via radiography on both sides during a follow-up 9 years postoperatively in a (b)(6) female patient.

• 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 dr.; carlsbad, CA 92008 ; 7602165137
• MDR Report Key: 11638920
• MDR Text Key: 246664154
• Report Number: 3001503333-2021-00001
• 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: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 804018
• Device Catalogue Number: 804018
• Device Lot Number: 200550B/200551B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2021
• 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: 83 YR