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 swiss hospital regarding osteolysis.The inquiry received on 16sep2015 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 swiss 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 2 of the 2 patients.The narrative and details of this event have been translated from german as follows: translation of source document in (b)(4) language received on september 30th 2015: diagnoses: tatus post total arthroplasty left hip due to coxarthrosis on (b)(6) 2009; tatus post total arthroplasty right hip dated (b)(6) 2005; secondary diagnoses: tatus post distal radius fracture right (b)(6) 20126 tatus post complex foot injury left (b)(6) 2012; coronary and hypertensive heart disease; arterial hypertension.Progression: we carried out the scheduled radiological/clinical follow-up 10 and/or 5 years postoperatively for the aforementioned hip prostheses.The patient is very satisfied, she only has pain sensations when the weather changes.The patient regularly goes for walks with walking sticks.Findings: gat with small steps and without limping.Flexion 120°., extension 0°.External rotation/internal rotation right 20/0/10°, external rotation/internal rotation left 30/0/10°.No inflammation of the scar tissue.X-ray: pelvic overview aligned low centrally , right hip axially dated (b)(6) 2015: regular position of the prosthetic material only with osteolyses at synplug, otherwise no evidence for loosening.Further procedure due to the very good postoperative progress and satisfied patient we will conclude our follow-up.Should the patient have any new complaints she may contact us again at any time.

• 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: 5147159
• MDR Text Key: 28138587
• Report Number: 2090010-2015-00042
• 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: 09/16/2015

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