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U.S. Department of Health and Human Services

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

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ISOTIS ORTHOBIOLOGICS, INC SYNPLUG - UNKNOWN SIZE Back to Search Results
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 the (b)(4) national competent authority ((b)(4)) 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 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 22 mdr's for these reports.Should the additional information indicate any of the 22 adverse events relate 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 22 of the 22 patients.The narrative and details of this event have been translated from german 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 casual 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 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.
 
Event Description
Previous medwatch filed without suspect medical device name.
 
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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 Key4917982
MDR Text Key6025219
Report Number2090010-2015-00029
Device Sequence Number1
Product Code LZN
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K010840
Number of Events Reported1
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 NumberXXX-SYNPLUG
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/15/2015
Initial Date FDA Received07/13/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received08/06/2015
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 Number1
Patient Outcome(s) Other;
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