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 Date 10/31/2022

Event Type  malfunction  

Event Description

Osteolysis in the area of the synplug was observed via radiography on both sides during a follow-up 10 years postoperatively (right side / 3001503333-2022-00003) and 15 years postoperatively (left side / 3001503333-2022-00004).

Manufacturer Narrative

The radiographs provided indicate the biodegradable cement restrictor has degraded; literature suggests further deterioration of the hip prosthesis may occur, placing the joint at risk of fracture.Although it is associated with osteolysis, it is not clear if the phenomenon is caused by the device or if other physiologic processes/interactions are contributory.Field safety corrective action (fsca-o-hhe-701) was undertaken to provide safety alert to physicians regarding the possible risk.At or around that time (2014), market withdrawal and destruction of unused product occurred.The prosthesis remains implanted; no revision has occurred.This is consistent with the majority of similar reports.

• 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: 15993810
• MDR Text Key: 308558444
• Report Number: 3001503333-2022-00004
• 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: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• 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: 115.811/B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2022
• 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