MAUDE Adverse Event Report: MAKO SURGICAL RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS

Model Number 180708-1

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/21/2013

Event Type  malfunction  

Event Description

Upon receipt at the hospital, the mako representative noted that the pn 180408 (patellofemoral component, size 8) implant from the pn 150135 (serial #(b)(4)) implant shipping container appeared to have an unidentified stain present under the shrink wrap on the box label.This implant was separated and placed in a ziploc bag for return.Two implants from the kit, which exhibited no visible damage, were used in the case.The remaining implants were returned (total returned qty.15) to mako for evaluation.

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event was completed at mako surgical.A non-conforming report (npr) was created.The packaging configuration of the product referenced in npr (b)(4) consists of two redundant sterile barriers (tyvek envelopes), encased by a rigid plastic box, and shrink wrapped.The stain on the product (alleged to be mold) was noted on the label of the rigid plastic box.All product returned was visually inspected by a team of engineers.The inspection consisted of visually inspecting each layer of packing for discoloration.The engineer leading the inspection noted that none of the product returned had discoloration past the outer ridged plastic box.Mako has also followed up with the surgeon who implanted the device from the same kit of (b)(4) devices.The surgeon reported that the patient had no infection or post-operative complications.The (b)(4) returned units have been scrapped.

• Brand Name: RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS
• Type of Device: COMPARTMENTAL KNEE PROSTHESIS
• Manufacturer (Section D): MAKO SURGICAL; ft. lauderdale FL
• Manufacturer Contact: william tapia ; 2555 davie rd.; ft. lauderdale, FL 33317 ; 9546280605
• MDR Report Key: 4209159
• MDR Text Key: 17581249
• Report Number: 3005985723-2014-00141
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/21/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 180708-1
• Device Lot Number: 12230213-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/21/2013
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO)