MAUDE Adverse Event Report: ISOTIS ORTHOBIOLOGICS, INC SYNPLUG CEMENT RESTRICTOR; CEMENT OBTURATOR, PRODUCT CODE: LZN

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bone Fracture(s) (1870); Osteolysis (2377)

Event Date 08/01/2018

Event Type  Injury  

Manufacturer Narrative

Radiographs were provided for review images received did not detect osteolysis at the proximal end of the prosthetic shaft.A medical review of the radiograph notes, what is noted as osteolysis is most likely radio residual cement plug.If anything the femoral cortical bin looks almost normal.Less than normal cement distal to femoral stem.The plug would not play a significant role in the fracture.Looks like the fracture occurred proximal to the plug, at the end of the cement mantel.Root cause analysis: within in medical probability, at 11 years, the synplug did not cause or contribute to the femur fracture, left.Though the 11 year post-operative event was alleged to involve synplug, 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.A risk/benefit analysis of two reported fractured, 58 reported osteolysis without the need for medical intervention and 100,000+ patients benefiting from a successful surgery it can be concluded that the benefit outweighs the risk.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, with weber straight shaft ss, fitmore cup size 52, durasul inlay size 32, cobalt chrome head size 32 medium, palacos cement, synplug cement restrictor size 1, left side occurred (b)(6) 2007.A fracture on left side required surgery on (b)(6) 2018.Surgery consisted of open, reposition and compound osteosynthesis of left femur with palacos cement and ncb plate, left femur, on (b)(6) 2018.

• Brand Name: SYNPLUG CEMENT RESTRICTOR
• Type of Device: CEMENT OBTURATOR, PRODUCT CODE: LZN
• Manufacturer (Section D): ISOTIS ORTHOBIOLOGICS, INC; irvine CA 96218
• Manufacturer Contact: aaron ; 5770 armada drive; carlsbad, CA 92008
• MDR Report Key: 8087218
• MDR Text Key: 127851116
• Report Number: 2090010-2018-00005
• Device Sequence Number: 1
• Product Code: LZN
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: KO10840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2018
• 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: 82 YR