MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. SUBCHONDROPLASTY KNEE KIT 5CC 11 GA SIDE DELIVERY; CONVENIENCE KIT- 5CC CALCIUM PHOSPHATE COMPOUND BONE VOID FILLER WITH CANNULA

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

(b)(6), local zimmer sales representative, became aware of the event after a hallway conversation with dr.(b)(6) in which he inquired how his subchondroplasty procedure patients were doing.It was at that time that dr.(b)(6) informed (b)(6) of the patient death that had occurred in (b)(6) 2016.On (b)(6) 2016 (b)(6) had a brief phone conversation with dr.(b)(6) about the case.The patient was a (b)(6) year old female with a past history of hypertension.Dr.(b)(6) stated that he estimates that he had injected 3cc of accufill material into the tibial plateau per the recommended surgical technique.No tourniquet was used.He stated that the procedure went as planned without incident and that the patient was discharged to home with minimal postoperative pain.It was then while the patient was home days after the procedure that the medical event occurred.A family member found the patient unresponsive at home.The patient was taken to the emergency room, but expired.The event was initially reported to zimmer biomet as a pulmonary embolism.However, dr.(b)(6) stated that an autopsy was never performed, that the er staff had suggested a pulmonary embolism, but that this could not be concluded without an autopsy.Unfortunately, at the time of this report, medical records from the emergency room were not available for review.Dr.(b)(6) also stated that he inquired of a colleague at another institution that has performed several hundred of these procedures to see if that surgeon uses dvt prophylaxis and he stated that he does not.Dr.(b)(6) stated that given the age and health status of the patient, he did not believe dvt prophylaxis was indicated.Dr.(b)(6) stated that he did not believe the patient death was related to subchondroplasty procedure or the accufill injection.

Event Description

Death of a patient reported via telephone from a case in (b)(6) 2016.

• Brand Name: SUBCHONDROPLASTY KNEE KIT 5CC 11 GA SIDE DELIVERY
• Type of Device: CONVENIENCE KIT- 5CC CALCIUM PHOSPHATE COMPOUND BONE VOID FILLER WITH CANNULA
• 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: 6234389
• MDR Text Key: 64239324
• Report Number: 3008812173-2017-00002
• 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: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/13/2016

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: 09/20/2019
• Device Model Number: N/A
• Device Catalogue Number: 414.502
• Device Lot Number: KC03349
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/13/2016
• Initial Date FDA Received: 01/09/2017
• 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): Death
• Patient Age: 63 YR