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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 04/12/2016

Event Type  Injury  

Manufacturer Narrative

The patient involved in this complaint is a female, age (b)(6) at the time of the initial subchondroplasty procedure.The patient was initially evaluated by dr.(b)(6) and diagnosed with right knee degenerative joint disease, medial and lateral menisci tears and insufficiency fracture of the medial femoral condyle.The patient had failed to respond to prior conservative therapies including cortisone injections prior and medications including indomethacin, diclofenac sodium, hydrocodone bitartrate and ibuprofen.The patient decided to procedure with surgical intervention including knee arthroscopy and subchondroplasty to treat the insufficiency fracture.The patient also consented to participate in the (b)(6) clinical study of (b)(6).She reported a preoperative pain level of 8/10 and an ikdc score of 10.31.The patient had surgery with dr.(b)(6) on (b)(6) 2015.Dr.(b)(6) first treated the insufficiency fracture.Using fluoroscopy for guidance, an accuport cannula was placed in the medial femoral condyle in the proximity of the insufficiency fracture identified on preoperative mri.The bone lesion was then injected with 5 cc of accufill.The material was allowed to harden for 12 minutes prior to removal of the accuport cannula.A/p and lateral x-ray images confirmed proper placement of the accufill material.The arthroscope was then placed in the knee.The acl had a small stretch; the pcl was intact.The medial meniscus showed full thickness tearing that was resected approximately 1/3 at the mid-body junction.The lateral condyle showed grade iii changes and chondroplasty was performed.The patella showed grade iii changes and was treated with chondroplasty.Multiple loose bodies were found with the knee, the largest being 1 cm in size.A medial meniscectomy was also performed.The knee was also injected with kenalog and marcaine at the time of the procedure.The patient was discharged without reported complications.The patient initially showed improvement in knee pain to 4/10 and improvement in ikdc score to 22.8 at 6 weeks after the procedure.However, the patient received a cortisone injection in the knee on (b)(6) 2016 for continued symptoms.On (b)(6) 2016, the patient was evaluated by dr.(b)(6), dr.(b)(6) partner, for continued bilateral osteoarthritis symptoms with the right knee being worse.During that visit, the patient reported a knee pain level of 8/10, primarily in the medial compartment.X-rays obtained during the visit demonstrated severe medial joint space narrowing with marginal osteophyte formation and periarticular sclerosis and cysts in the right knee.The patient decided to proceed with total knee arthroplasty.Dr.(b)(6) performed total knee arthroplasty on the patient's right knee on (b)(6) 2016.The procedure was completed without reported complications.No mention was made of the use of bone grafts or augments used and the status of the bone at the prior accufill injection site was not mentioned.At 2 weeks following the tka, the patient appeared to be progressing as expected.At six weeks after the tka, the patient was complaining for severe knee pain, increased with activity, and was given a kenalog injection.Weight loss and a medial unloader brace was also recommended.Dr.(b)(6) reported an adverse event for the degenerative joint disease progressing to total knee arthroplasty as part of the (b)(6) clinical study.Dr.(b)(6) indicated that the ae was severe and "possibly related" to both the device and procedure.

Event Description

Patient received tka after scp.

• Brand Name: ACCUFILL
• 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: 6307065
• MDR Text Key: 66713786
• Report Number: 3008812173-2017-00006
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/09/2017

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 Model Number: N/A
• Device Catalogue Number: 201.050
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/09/2017
• Initial Date FDA Received: 02/07/2017
• 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: 60 YR
• Patient Weight: 93