MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. KNEE CREATIONS SUBCONDROPLASTY KNEE KIT - 5CC; BONE SUBSTITUTE MATERIAL

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/17/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The product was evaluated through manufacturing review, however, the reported event could not be confirmed.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.This report was previously submitted erroneously on mar 25, 2020 under manufacturing report number 0001822565-2020-01038.

Event Description

It was reported that during knee subchondroplasty, the tip of the cannula that was used to insert the cement into the patient's bone fractured upon insertion.The fractured portion remained in the patient as the physician chose not to extract it.No additional adverse consequences were reported.Attempts have been made and no additional information is available.

• Brand Name: KNEE CREATIONS SUBCONDROPLASTY KNEE KIT - 5CC
• Type of Device: BONE SUBSTITUTE MATERIAL
• 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: leo munar ; 841 springdale drive; exton, PA 19341 ; 4848794553
• MDR Report Key: 10437358
• MDR Text Key: 203858780
• Report Number: 3008812173-2020-00013
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 414.502
• Device Lot Number: KC06078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2019
• 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