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

Catalog Number XXX-SYNPLUG

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Event Description

Integra received an inquiry from the (b)(4) regarding reports they had received from a (b)(6) hospital regarding osteolysis.The inquiry received on 07/08/2015 indicated adverse events for 3 patients had been reported to the authority.At this time, it is unclear if the information provided to integra by the authority 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 3 mdr's for these reports.Should the additional information indicate any of the 3 adverse events relate to patient/adverse events integra has already provided mdr's for, it will be noted in a follow-up mdr.This report is for patient 2 of the 3 patients.The narrative and details of this event have been translated from (b)(6) as follows: diagnose: status post total hip prosthesis implant on the right side of (b)(6) 2010 with coxarthritis on the right side; very minimal osteolyses with synplug cement block; mild coxarthritis on the left side; multiple myeloma.Progression: the planned clinical/radiological progress check-up takes place 5 years after the implantation of the hip tp.The patient is very satisfied with the results and also goes for walks and hikes regularly without feeling any pain.From time to time, there are still the known bursitis trochanteria complaints, which, however, rapidly pass again with application of ointment and mild rest.There are only mild complaints regarding the left hip.Findings: fluid gait.The pelvis is straight.Unirritated scar conditions on the right hip joint in the anterior region.Mild pain on compression over the trochanter major on the right side.No pain when shaking, no axial shock pain.No other pain on compression, no impingement pain.The range of motion is as follows in extension/flexion of the right hip: 0/0/125, outer rotation/inner rotation 45/0/35.The peripheral dms [unidentified] is intact.

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 biodegradeable 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 findings 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 - UNK SIZE
• Type of Device: SYNPLUG
• Manufacturer (Section D): ISOTIS ORTHOBIOLOGICS, INC; irvine CA 96218
• Manufacturer Contact: maria leonard ; 311 enterprise dr.; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 4972574
• MDR Text Key: 6073553
• Report Number: 2090010-2015-00031
• 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,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2015
• 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
• Date Manufacturer Received: 07/08/2015
• 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): Required Intervention
• Patient Age: 86 YR