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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 07/18/2013

Event Type  Injury  

Manufacturer Narrative

This complaint is based on a clinical study review.The investigation is still in-progress.A supplemental mdr will be submitted once the investigation is completed.Not available.

Event Description

Not related to device or procedure adverse event.

Manufacturer Narrative

The patient involved in this complaint was a (b)(6) female collegiate athlete at the time she saw dr.(b)(6) on (b)(6) 2011.The patient reported bilateral anterior knee pain beginning in 2006.An arthroscopy with chondroplasty of the left patella with loose body removal was performed in (b)(6) 2007.She was diagnosed with patellar malalignment and underwent tuberosity medialization with lateral release on the left knee (b)(6) 2010.The operative notes state there was a 20mm diameter grade 3 lesion of the patella at the surgery.In (b)(6) 2011 subject underwent hardware removal.During a clinical visit with dr.(b)(6) on (b)(6) 2011, subject stated she had no new injury but had increasing anterior knee pain.The patient underwent suchondroplasty (b)(6) 2012 to treat a bone marrow lesion in the central portion of the patella and was enrolled in the (b)(4) clinical study.The patient continued to have persistently symptomatic patellar chondrosis despite normal tt-tg distance.Dr.(b)(6) assessed this adverse event as mild and not related to the subchondroplasty procedure or device.The patient elected to undergo autologous chondrocyte implantation with straight anteriorization of the tubercle of the left knee on (b)(6) 2012.During subject post-operative clinical visit on (b)(6) 2012, dr.(b)(6) noted symptomatic patellar chondrosis adverse event to be resolved.However, during a clinical visit with dr.(b)(6) on (b)(6) 2013, the subject reported she had developed increased anterior pain and crunching sensation following an incident while playing basketball.Dr.(b)(6) assessed this adverse event as mild and not related to the original subchondroplasty procedure or device.Dr.(b)(6) also noticed less quadriceps girth in her left vs right leg.Dr.(b)(6) completed a diagnostic arthroscopy on (b)(6) 2013 with partial synovectomy, scar tissue removal, along with removal of tuberosity deep hardware from the previous surgery.Dr.(b)(6) noted that the site of the previously performed autologous chondrocyte transplantation appeared to be well filled an integrated with only minor fraying and softening of the repair tissue.Dr.(b)(6) noted increased synovial tissue in the parapatellar region and scar tissue which may have been a contributing factor to her pain.During the patient's post-operative clinical visit on (b)(6) 2013, subject reported a decrease in grinding and dr.(b)(6) believed patient's adverse event of increased parapatellar synovium and scar to be resolved.Imaging and the operative notes for the subchondroplasty procedure were not available at the time of this investigation so it is not known if the recommended surgical technique was followed or what volume of accufill was used.The patient symptoms associated with the increased synovium and scar tissue appear to be most related to prior autologous chondrocyte implantation procedure which was performed through an open procedure with a 10 cm incision.

Event Description

After several previous left knee procedures, including subchondroplasty, subject continued to have persistently symptomatic patellar chondrosis and underwent autologus chondrocyte implantation with straight anteriorization of the tubercle of the left knee on (b)(6) 2012.During a clinical visit with dr (b)(6) on (b)(6) 2013, the subject reported she had developed increased anterior pain and crunchong of patellar carticel.Dr (b)(6) completed a diagnostic arthroscopy with partial synovectomy, scar tissue removal, along with removal of tuberosity deep hardware for this subject on (b)(6) 2013 due to subject's patellofemoral activity-related pain with history of carticel implant to the patella.During subject on (b)(6) 2013 due to subject's patellofemoral activity-related pain with history of carticel implant to the patella.During subject's post-operative clinical visit on (b)(6) 2013, subject reported a decrease in grinding and dr.(b)(6) believed subject's mild adverse event(not related to device or procedure) to be resolved.

• Brand Name: ACCUFILL 5CC
• Type of Device: CALCIUM PHOSPHATE 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: shari bailey ; 841 springdale drive; exton, PA 19341 ; 4848794543
• MDR Report Key: 6142059
• MDR Text Key: 61344585
• Report Number: 3008812173-2016-00032
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/30/2017

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: 11/07/2016
• Initial Date FDA Received: 12/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/30/2017
• 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: 25 YR
• Patient Weight: 87