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 Date 11/20/2014

Event Type  Injury  

Manufacturer Narrative

Integra completed its internal investigation 25jan2016.The investigation included: method: - review of device history records.- review of complaint management database for similar complaints.Results: the synplug product size and lot number (most likely) will not be provided given the information in the complaint (implanted product some time ago), therefore it is not possible to conduct a dhr review for potential anomalies that might be associated with the alleged complaint.The complaint database was reviewed for the last two years and indicated there were other related complaints for osteolysis observation.Conclusion: 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

It was reported postoperative osteolysis was identified for this patient.Translation received on 26 january 2016: diagnosis, status post change of total hip arthroplasty right dated (b)(6) 2014, status post total hip arthroplasty left (syn plug osteolysis prosthesis tip), progression.Patient presented as scheduled for the 1 -year follow-up with us he reported about a significant improvement of the initial pain symptoms.Currently he sensed only a certain tiredness of the two legs he reported to be slightly restricted, only because of this weakness, with a walking distance from 1-2h.Otherwise the patient is extremely content and no longer restricted by pain symptoms findings fluid gait without limping.Even leg lengths.Pain free movement in the right hip joint with flexion/extension 120-0-0° internal rotation/external rotation 10-0-30°.The surgery scar has healed without irritation.X-ray pelvic overview and right hip axially: former osteotomy area right completely built up with bone.Position of the total hip arthroplasty as before without signs of loosening.Syn plug osteolysis distally from the prosthesis shaft after total hip arthroplasty left.Further procedure we are seeing a most pleasing progress in patient.Overall he is very content.The next follow-up appointment is planned for 5 years postoperative.Continued clinical and radiological monitoring of the syn plug osteolyses of the left prosthesis shaft.

• 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 b; irvine CA 96218
• Manufacturer Contact: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5434919
• MDR Text Key: 38208468
• Report Number: 2090010-2016-00002
• 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,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2016
• 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
• Date Manufacturer Received: 01/18/2016
• 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
• Patient Age: 77 YR