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

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.This report is for patient 1 of the 2 patients.The narrative and details of this event have been translated from (b)(6) as follows: translation of the source document in (b)(6) language received on september 30th 2015 : diagnoses: pain in the region of the attachment point of the tensor fasciae latae muscle with: status post left hip arthroplasty dated (b)(6) 2003 (dr.(b)(6)) and with: secondary dislocated medial femoral neck fracture post screw osteosynthesis dated (b)(6) 2003.Secondary diagnoses: multiple myeloma lgg kappa (initial diagnosis 2005).Currently: raised paraprotein lgg (new course of chemotherapy) status post bullous variant of sweet's syndrome 2008.Coronary heart disease and generalised macroangiopathy; status post bilateral pulmonary embolism; chronic renal insufficiency; autoimmune polyglandular syndrome type 3; progress: [redacted] is arriving today for the scheduled follow-up visit 2 years after the previous check-up.The pain that [redacted reported in 2013, (10 years postoperatively), have subjectively improved.He report that he has no problems to travel on foot for 5 hours.The known pain in the region of the attachment point of the tensor fascie latae muscle occurs on some days only and can be independently eliminated by light mobilisation exercises.Findings: gait without limping.Level pelvis.No inflammation of the soft tissue.No reddening, no swelling, no hyperthermia in the region of the surgery area on the hip.No pain on compression.Flexion/extension 120/0/0 degrees, internal/external rotation 0/0/30 degrees, abduction/adduction 50/0/10 degrees.X-ray: pelvic overview and left hip axially: normal position of the prosthesis.No evidence for loosening.Regional reaction of the bone to synplug cement barrier, distal to the prosthesis shaft.This is unchanged in comparison with the image dated 2013.Further procedure: since the pain symptoms of the patient have improved since 2013, there is no indication, as far as we are concerned, to indicate further measures.We recommend to the patient to use a walking stick for long distances.The osteolyses perifocal to the cement barrier need ongoing monitoring.Next check-up with x-ray in two years' time with [redacted]during regular consulting hours.Should the pain increase, we would ask that the patient contacts us again.

• 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 Key: 5147122
• MDR Text Key: 28140185
• Report Number: 2090010-2015-00039
• Device Sequence Number: 1
• Product Code: LZN
• Combination Product (y/n): N
• PMA/PMN Number: K010840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Dental Hygienist
• Report Date: 09/22/2015

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 Number: XXX-SYNPLUG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2015
• 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): Disability