MAUDE Adverse Event Report: ISOTIS ORTHOBIOLOGICS, INC OPTIPLUG CEMENT RESTRICTOR; CEMENT OBTURATOR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bone Fracture(s) (1870); Hip Fracture (2349)

Event Date 07/02/2016

Event Type  Injury  

Manufacturer Narrative

Report alleging the event was received from (b)(6) on 12/7/2016.Radiographs were noted to be enclosed to (b)(6).After requests to (b)(6) and to the doctor, no radiographs confirming the event were received.No medical evaluation could be performed.It is unknown if there are allegations of osteolysis.The complaint of peri-prosthetic fracture can not be confirmed.There is a current plan for revision, but the patient status is unknown.Patient activity level at the time or prior to the event is unknown.Patient's bone quality is unknown.It is unknown if the patient complied with post-operative care instructions or sustained a fall/impact of some sort.It is unknown if the concomitant device (hip prosthesis) or bone cement contributed to the event.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

Initial hip replacement (hip arthroplasty) surgery involving a hip prosthesis, thp cement, and optiplug cement restrictor occurred on (b)(6) 2012.Allegedly on (b)(6) 2016 patient incurred a peri-prothesis fracture near the hip prosthetic.(b)(6), references a radiograph depicted a fracture but radiographs were not forwarded on to manufacturer.The fracture resulted in a need for medical intervention/revision.Patient status post revision is unknown.

• Brand Name: OPTIPLUG CEMENT RESTRICTOR
• Type of Device: CEMENT OBTURATOR
• Manufacturer (Section D): ISOTIS ORTHOBIOLOGICS, INC; irvine CA 96218
• Manufacturer Contact: peter perhach ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165681
• MDR Report Key: 6197245
• MDR Text Key: 63055825
• Report Number: 2090010-2016-00008
• Device Sequence Number: 1
• Product Code: LZN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K010840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/07/2016

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: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2016
• Initial Date FDA Received: 12/21/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR