MAUDE Adverse Event Report: ISOTIS ORTHOBIOLOGICS, INC SYNPLUG - UNKNOWN SIZE

Catalog Number XXX-SYNPLUG

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tissue Damage (2104); Osteolysis (2377)

Event Type  Injury  

Event Description

It was reported the patient has a huge osteolysis around the synplug cement restrictor implanted with a total prosthesis in 2011.The patient is symptomatic and needs revision surgery.Additional information has been requested.

Manufacturer Narrative

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.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.

• Brand Name: SYNPLUG - UNKNOWN SIZE
• Type of Device: SYNPLUG
• Manufacturer (Section D): ISOTIS ORTHOBIOLOGICS, INC; 2 goodyear place, suite a; 2 goodyear place, suite a; irvine CA 96218
• Manufacturer (Section G): ISOTIS ORTHOBIOLOGICS, INC; 2 goodyear place, suite a; irvine CA 96218
• Manufacturer Contact: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5180828
• MDR Text Key: 29369539
• Report Number: 2090010-2015-00045
• Device Sequence Number: 1
• Product Code: LZN
• Combination Product (y/n): N
• PMA/PMN Number: K010840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Dental Hygienist
• Type of Report: Initial,Followup
• Report Date: 10/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-SYNPLUG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2015
• Initial Date FDA Received: 10/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/25/2015
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability