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

Catalog Number XXX-SYNPLUG

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Tissue Damage (2104); Therapeutic Response, Decreased (2271)

Event Type  Injury  

Event Description

Integra received an inquiry from (b)(6) regarding reports they had received from a (b)(6)hospital regarding loosening of hip arthroplasty femoral components and osteolysis.The inquiry indicated adverse events for 22 patients had been reported to (b)(6).At this time, it is unclear if the information provided to integra by (b)(6) regards patients/adverse events integra has already provided mdr's for or if they relate to new patients/adverse events.Integra has contacted the (b)(6) hospital directly to ascertain this as well as additional information and in the interim is submitting 22 mdr's for these reports.Should the additional information indicate any of the 22 adverse events related to patients/adverse events integra has already provided mdr's for, it will be noted in a follow-up mdr.This report is for patient 18 of 22 patients.The narrative and details of this event have been translated from (b)(6) as follows: synplug and aseptic loosening of the femoral component "we have provided you with a list of patients, who have suffered, a) aseptic loosening of the femoral component and, b) extensive osteolysis, c) osteolysis with a thinning of the corticalis.General additional information provided: the osteolysis cases were first discovered at the 1 year monitoring visits.Initially, little attention was paid to these phenomena.Many osteolysis (incidents) were only visible in appropriate radiological x-ray investigations.The osteolysis became more apparent subsequently at the 5-year monitoring visit.Of the 22 patients reported for this event, revision surgery was carried out in all patients with aseptic loosening of the femoral component and in some it was possible to carry out a histological analysis of the bone perifocal to the synplug cement barriers.X-ray images are available for the 22 patients that have been affected.

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 and 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.

Manufacturer Narrative

Previous medwatch filed without suspect medical device name.

• Brand Name: SYNPLUG - UNKNOWN SIZE
• Type of Device: SYNPLUG
• Manufacturer (Section D): ISOTIS ORTHOBIOLOGICS, INC; irvine CA 92618
• Manufacturer Contact: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 4917998
• MDR Text Key: 6430816
• Report Number: 2090010-2015-00025
• 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,User Facility,Company Representative,Distributor,company represent
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2015

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?: No
• Initial Date Manufacturer Received: 06/15/2015
• Initial Date FDA Received: 07/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/12/2015
• 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): Other