• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ISOTIS ORTHOBIOLOGICS, INC SYNPLUG - UNKNOWN SIZE Back to Search Results
Catalog Number XXX-SYNPLUG
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Tissue Damage (2104)
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® & 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)) regarding reports they had received from a (b)(6) hospital regarding osteolysis.The inquiry received on (b)(4) 2015 indicated follow up for an adverse event had been reported to the authority.At this time, it is unclear if the information provided to integra by the authority regards a patient / adverse event integra has already provided an mdr's for or if this relates to a new patient / adverse event.Integra has contacted the (b)(6) hospital directly to ascertain this as well as additional information and in the interim is submitting this mdr.Should the additional information indicate the adverse event relates to patients / adverse events integra has already provided mdr's for, it will be noted in a follow-up mdr.Translation of source document in (b)(6) language received in (b)(4) 2015 : diagnosis: persistent enthesitis with status post implantation of a total left hip prosthesis 2004.- discrete osteolysis perifocal to the synplug cement restrictor.- exclusion of possible loosening of femoral component, by means of scintigraphic imaging dated (b)(6) 2014.- status post implantation of a total external right knee prosthesis [deleted] with: - chronic right knee pain > left, with especially pronounced right chondrocalcinosis.- chronic lumbosciatica with status post dorsal spinal fusion l2-s1.Progress: as planned, we are reviewing ms [deleted] in our consultation, now eleven years post implantation of the total left hip prosthesis.Ms [deleted] reports the same ongoing clinical findings with persisting pain symptoms in the region of the left hip and in the region of the entire left thigh.The pain predominantly occurs after long periods of mobilisation, but also on waking in the morning.There has been no observed change in symptoms over the past months and years.In terms of the chronic right knee pain, ms [deleted] has been operated on by mr [deleted].A total knee prosthesis was implanted 6 months ago.Ms [deleted] is very satisfied with the progress in the region of the right knee and describes a marked improvement since the operation.Findings: minimally limping gait with a 1 cm clinical leg length discrepancy to the detriment of the right side.Free range of movement of the left hip with flexion/extension at 110-0-0 degrees.Internal/external rotation 40-0-20.The strong internal rotation is pain-free; the restricted external rotation is painful.No tenderness on palpation over the greater trochanter.Discrete inguinal tenderness on palpation.The patient feels definite pain symptoms both proximally and distally in the lateral, medial and anterior thigh.It remains unclear to what extent this may also be caused by a spinal problem.Diffusely, there is a marked reduction in sensation indicated in the l2 and l3 dermatome.Right knee: non-tender healed wound.Free range of movement with flexion/extension at 110-0-0 degrees.Ligamentously stable knee joint.Unremarkable examination overall, 6 months post implantation of a tkp.X-rays: pelvic and axial views of the left hip dated (b)(6) 2015: unchanged position of the hip prosthesis without signs of loosening or periprosthetic fracture.Still unchanged osteolysis perifocal to the synplug cement restrictor.There is also an eccentric abrasion of the inlay.Further procedure: ms [deleted] displays persisting chronic pain symptoms in the region of the left hip and left thigh.Radiologically we can find no evidence of a change in position or stability of the prosthesis.Ms [deleted] is extremely satisfied with the right knee joint region following implantation of a total knee prosthesis by mr [deleted].For the eccentric abrasion of the inlay in the region of the left hip, we recommend a clinical and radiological follow-up at the clinic in 3 years time.In the event of increasing symptoms, an earlier consultation can, of course, be arranged in our clinic.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SYNPLUG - UNKNOWN SIZE
Type of Device
SYNPLUG
Manufacturer (Section D)
ISOTIS ORTHOBIOLOGICS, INC
2 goodyear place, suite a
2 goodyear place, suite a
irvine CA 96218
Manufacturer (Section G)
ISOTIS ORTHOBIOLOGICS, INC
2 goodyear place, suite a
irvine CA 96218
Manufacturer Contact
maria leonard
311 enterprise drive
plainsboro, NJ 08536
6099362393
MDR Report Key5159717
MDR Text Key28673107
Report Number2090010-2015-00043
Device Sequence Number1
Product Code LZN
Combination Product (y/n)N
PMA/PMN Number
K010840
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Dental Hygienist
Report Date 09/23/2015
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 Received10/19/2015
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) Disability;
-
-