MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. ACCUFILL 5CC; CALCIUM COMPOUND BONE VOID FILLER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 11/24/2015

Event Type  Injury  

Manufacturer Narrative

The patient underwent total knee arthroplasty of the right knee on (b)(6) 2014 for end-stage osteoarthritis.The surgery was performed by (b)(6), md.After the procedure, the patient continued to present with discomfort of the right knee which dr.(b)(6) attributed to tibial loosening at the baseplate of the implant.In an attempt to stabilize the implant and prevent a total revision, dr.(b)(6) elected to perform percutaneous injection of accufill under the tibial implant in a procedure on (b)(6) 2015.Under fluoroscopy, an end-targeted accuport was placed under the tibial implant in a space of maximal tenderness.The accufill material was then injected under the fluoroscopic guidance.There was no mention of the accufill volume used during the procedure, however, a single 5 cc accufill kit was utilized.After waiting 8 minutes, the accuport was removed.The wound was then irrigated, sutured and injected with 0.5% marcaine.In an operative note on (b)(6) 2015, dr.(b)(6) described the patient presenting with some pain with drainage at the inferior aspect of his medial tibia.X-rays revealed multiple foreign bodies in the prepatellar fascia.Crp was negative for infection.Bone scan demonstrated no evidence of infection or implant loosening.On (b)(6) 2015, the patient underwent a procedure for removal of the foreign bodies.A longitudinal skin incision was made and carried through the soft tissues.Multiple "nuggets" of accufill were found in the fascial and prefascial regions.These were removed manually and irrigated.Cultures were obtained after removal of the material.After no further foreign bodies were found, the wound was irrigated with antibiotics.The wound was first closed deep and then vancomycin sprinkles were place at the wound.The sinus was then debrided and left open.Antibiotic sprinkles were placed superficially and the wound was closed with sutures and skin staples.The wound was then injected with 0.5% marcaine and a sterile compressive dressing was applied.No further postoperative notes are available at the time of this investigation.No information has been received indicating the wound tested positive for infection.No intraoperative or immediately postoperative images were available at the time of this investigation.Consequently, it cannot be confirmed whether or not the accufill material extravasated out of the bone at the site of accuport placement, between the loosened tibial baseplate and bone or at another site at the time of the initial injection procedure.Device was not returned.

Event Description

Patient had received a total knee on (b)(6) 2014 and had scp on (b)(6) 2015.

• Brand Name: ACCUFILL 5CC
• Type of Device: CALCIUM COMPOUND BONE VOID FILLER
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• Manufacturer (Section G): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• Manufacturer Contact: victor krone ; 841 springdale drive; exton, PA 19341 ; 4848794224
• MDR Report Key: 6061621
• MDR Text Key: 58541105
• Report Number: 3008812173-2016-00023
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/27/2016

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: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 402.203
• Device Lot Number: KC02075
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/27/2016
• Initial Date FDA Received: 10/27/2016
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR