MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. SUBCHONDROPLASTY; SCP KIT

Model Number N/A

Device Problem Biological Environmental Factor (2887)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/19/2017

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, the bone substitute material would not set in the patient, as the arthroscopy fluids were 73.4 degrees fahrenheit.There was a surgical delay of 50 minutes while the doctor waited for the bone substitute material to set.Since the surgical delay was over 30 minutes, this is being handled as a serious injury.However, the material was also tested in a warm water bath, and the device performed as expected.The investigation is ongoing.

Event Description

Accufill did not set up after the specified time waiting period of 10 minutes.

Manufacturer Narrative

When the procedure is performed on anatomical regions of the body where the temperature is lower than the core temperature, it is not uncommon for the accufill to take a little longer to set up.The surgeon no longer has any concerns and the patient status is normal at this time.

Event Description

Accufill did not set up after the specified time waiting period of 10 minutes.

• Brand Name: SUBCHONDROPLASTY
• Type of Device: SCP KIT
• 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: 7118204
• MDR Text Key: 94871024
• Report Number: 3008812173-2017-00027
• Device Sequence Number: 1
• Product Code: OJH
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2020
• Device Model Number: N/A
• Device Catalogue Number: 414.502
• Device Lot Number: KC04089
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2017
• 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
• Patient Age: 35 YR