MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. SUBCHONDROPLASTY KNEE KIT 5CC SIDE 11GA.X120MM; FILLER, BONE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/07/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complainant has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.H3 other text : investigation incomplete.

Event Description

It was reported that while the surgeon was utilizing the cannula to inject the bone substitute material during a knee subchondroplasty, the cannula fractured at the third fenestration and the tip was left in the patient.Attempts have been made, however, no additional information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and corrected 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.

Event Description

No further event information available at the time of this report.

• Brand Name: SUBCHONDROPLASTY KNEE KIT 5CC SIDE 11GA.X120MM
• Type of Device: FILLER, BONE
• 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: 13025062
• MDR Text Key: 282389059
• Report Number: 3008812173-2021-00005
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 00889024205314
• UDI-Public: (01)00889024205314(17)240506(10)209512321B
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2024
• Device Model Number: N/A
• Device Catalogue Number: 414.502
• Device Lot Number: 209512321B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2021
• 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 Sex: Prefer Not To Disclose