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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 Problem No Consequences Or Impact To Patient (2199)
Event Type  Injury  
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.
 
Event Description
Integra received an inquiry from the (b)(6) national competent authority (b)(6) regarding reports they had received from a (b)(6) hospital regarding osteolysis.The inquiry received on july 21 2015 indicated follow up for 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 patients / adverse events integra has already provided mdr's for, it will be noted in a follow-up mdr.This report is for patient 3 of the 3 patients.The narrative and details of this event have been translated from (b)(6) as follows: we herewith report to you about the outpatient examination (follow-up) of the aforementioned patient of (b)(6) 2015.Diagnoses status post total hip arthroplasty left dated (b)(6) 2005.Minimal osteolysis in the region of the cement barrier.Status post meniscectomy and di!bridement due to medial posterior meniscus horn lesion of the right knee dated (b)(6) 2005.Progression: the scheduled clinical/ radiological progress check-up takes place around 10 years after the implantation of the left hip tp.[redacted] continues to be pain free and can walker longer distances and no longer needs to take pain medication.Findings: left hip: scar conditions without irritation.No pain on compression.Flexion / extension 100/0/0 degrees.Inner rotation / outer rotation 15/0/30 degrees.X-ray: pelvic overview and hip joint left axially dated (b)(6) 2015: in comparison to previous images normal position of the hip-tp implant.No loosening of the component.There is merely a minimal osteolysis in the region of the cement barrier.Further procedure around 10 years post hip tp left the progression continues to be very satisfactory.Accordingly, our next clinical radiological progress check-up will take place in 5 years' time.An appointment will be scheduled accordingly in writing.
 
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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 dr.
plainsboro, NJ 08536
6099362341
MDR Report Key5006674
MDR Text Key23358163
Report Number2090010-2015-00035
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 company representative,distri
Reporter Occupation Physician
Report Date 07/21/2015
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 Not provided
Initial Date FDA Received08/13/2015
Was Device Evaluated by Manufacturer? No
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;
Patient Age73 YR
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