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 Known Impact Or Consequence To Patient (2692)

Event Date 11/20/2012

Event Type  Injury  

Manufacturer Narrative

During a clinical study review it was discovered that a patient who had received the subchondroplasty procedure later on received a total knee arthroplasty.Investigation is still on going so a supplemental to this mdr will be forthcoming once the investigation is completed.The issue was reported as such: subject was seen post-operatively (b)(6) 2012 with complaint of pain and swelling, along with signs of infection.The knee was aspirated and fluid was sent for cell count, culture and sensitivity, and gram stain.Due to subject¿s discomfort and malaise, arthroscopic lavage was performed with evacuation of hematoma on the same day and antibiotics were delivered.After this she was hospitalized due to septic knee and a picc line was started with vancomycin for 6 weeks per infectious disease consult.Subject had serial aspirations for cell count reports due to recurrence of effusion and high wbc count ranging from 34,000 to 40,000, however all cultures were negative.Subject was seen post-operatively (b)(6) 2012 with progression of knee infection.Additionally, subject displayed a full body rash and swelling in her hands and feet, which was attributed to an allergic reaction to her vancomycin therefore she was switched to daptomycin and given an epi pen.Following a second opinion to verify subject¿s septic condition, subject underwent diagnostic arthroscopy with lavage and light synovectomy with removal of all exudative material on (b)(6) 2012.Subject underwent an additional arthroscopic lavage (b)(6) 2012, as well as an additional diagnostic arthroscopy with lavage, decortication and drilling of lateral aspect of patella, extra articular and aspirate from knee sent for cell count and culture and sensitivity and bone biopsy sent for culture and sensitivity.During subject¿s post-operative visit on (b)(6) 2013, she reported intermittent sharp pain deep within her kneecap.She reported improvement, but no resolution of her swelling.Dr.(b)(6) suggested that if subject needed surgical intervention in the future she would be pre-approved for patellar osteochondral allograft transplantation, however he would like to postpone future surgery as long as possible.Dr.(b)(6) ultimately reported subject¿s septic knee of moderate severity, definitely related to scp procedure and possibly reported to the study device.He recorded the stop date of subject¿s septic knee to be (b)(6) 2013, the subject¿s post-operative clinic visit.

Event Description

Clinical subject.

Manufacturer Narrative

A review of documents has concluded that the swelling of the knee and subsequent "general feeling of malaise" could have been a result of the subchondroplasty procedure.However, this can't be confirmed as the culture and sensitivity reports were non-conclusive and no product was returned for analysis.

Event Description

Clinical subject was seen post-operatively (b)(6) 2012 with complaint of pain and swelling, along with signs of infection.The knee was aspirated and fluid was sent for cell count, culture and sensitivity, and gram stain.Due to subject¿s discomfort and malaise, arthroscopic lavage was performed with evacuation of hematoma on the same day and antibiotics were delivered.After this, she was hospitalized due to septic knee and a picc line was started with vancomycin for 6 weeks per infectious disease consult.Subject had serial aspirations for cell count reports due to recurrence of effusion and high wbc count ranging from 34,000 to 40,000, however all cultures were negative.Subject was seen post-operatively (b)(6) 2012 with progression of knee infection.Additionally, subject displayed a full body rash and swelling in her hands and feet, which was attributed to an allergic reaction to her vancomycin therefore she was switched to daptomycin and given an epi pen.Following a second opinion to verify subject¿s septic condition, subject underwent diagnostic arthroscopy with lavage and light synovectomy with removal of all exudative material on (b)(6) 2012.Subject underwent an additional arthroscopic lavage (b)(6) 2012, as well as an additional diagnostic arthroscopy with lavage, decortication and drilling of lateral aspect of patella, extra articular and aspirate from knee sent for cell count and culture and sensitivity and bone biopsy sent for culture and sensitivity.During subject¿s post-operative visit on (b)(6) 2013, she reported intermittent sharp pain deep within her kneecap.She reported improvement, but no resolution of her swelling.Dr.(b)(6) suggested that if subject needed surgical intervention in the future, she would be pre-approved for patellar osteochondral allograft transplantation, however he would like to postpone future surgery as long as possible.Dr.(b)(6) ultimately reported subject¿s septic knee of moderate severity, definitely related to scp procedure and possibly reported to the study device.He recorded the stop date of subject¿s septic knee to be (b)(6) 2013, the subject¿s post-operative clinic visit.

• 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: 6131867
• MDR Text Key: 61020061
• Report Number: 3008812173-2016-00030
• 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,Followup
• Report Date: 10/25/2016

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 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: 10/25/2016
• Initial Date FDA Received: 11/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2017
• 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; Required Intervention
• Patient Age: 28 YR
• Patient Weight: 78