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 23sep2015 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 german language received in september 30th 2015 : diagnoses symptomatic right trochanteric bursitis with status post right hip tp 2007, status post left hip tp 2004, status post left knee tp 2000, advanced right gonarthrisis.Status post left shoulder contusion and supraspinatus muscle lesion (b)(6) 2013.Status post right cts release 2011.Secondary diagnoses: chronic af (oac, marcoumar), status post cerebrovascular stroke 2011.Diabetes mellitus, hypertensive heart disease.Progress: scheduled follow-up post infiltration of the right trochanteric bursa.The patient has benefited from the infiltration; the patient has no further pain in that area.For some time, however, she has experienced pain higher up in the gluteal region, for which she has not taken any painkillers to date.Findings: limping gait.Equal leg lengths.No tenderness on palpation over the trochanteric bursa.Trendelenburg sign positive on the right.Hip joint symmetrical bilaterally and freely mobile.Age-appropriate reduced range of movement.Muscle tension and palpation tenderness in the right gluteal region.X-rays: pelvic and axial views of the right hip (b)(6) 2015: correct position of the prosthesis material, unchanged as compared to previous imaging, discrete osteolysis of the synplug on the left side.Further procedure: we consider the patient¿s pain in the right gluteal region to be part of muscular overstraining (enthesitis).We have recommended that the patient take analgesic, anti-inflammatory painkillers for 5-7 days and these have been prescribed.Clinically and radiologically the hip and knee joint prostheses are stable.Discrete synplug osteolysis left femur.We have not planned any further follow-ups; the patient will contact us if symptoms recur.

• 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: 5159687
• MDR Text Key: 28666779
• Report Number: 2090010-2015-00044
• 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: 09/23/2015

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 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: 10/19/2015
• 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 Number: 1
• Patient Outcome(s): Disability