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U.S. Department of Health and Human Services

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

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ISOTIS ORTHOBIOLOGICS, INC SYNPLUG - UNK SIZE Back to Search Results
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.
 
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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 Key4972574
MDR Text Key6073553
Report Number2090010-2015-00031
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,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
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? Yes
Initial Date Manufacturer Received 07/08/2015
Initial Date FDA Received08/03/2015
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) Required Intervention;
Patient Age86 YR
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