MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. KNEE CREATIONS SUBCHONDROPLASTY FOOT & ANKLE KIT 5CC 11G; FILLER, BONE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/04/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complainant has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It is reported that during a subchondroplasty procedure to address a lesion on the talus, the accuport cannula was identified to have been fractured.An x-ray was taken and the missing piece was identified within the talus.Multiple attempts were made to remove the fragment, however, the surgeon was unable to remove the remaining portion.There were no additional complications reported and the subchondral injection was able to be completed successfully into the lesion.Attempts have been made, however, no additional information is available at this time.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.The results of the investigation are as follows: visual inspection of the returned component noted it to exhibit signs of repeated use (nicked and gouged) and the threaded end is fractured.All pieces were not returned.The complaint is confirmed.A dimensional evaluation noted the product dimensions are conforming to specifications.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.This device is used for treatment.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after the investigation of this event.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: KNEE CREATIONS SUBCHONDROPLASTY FOOT & ANKLE KIT 5CC 11G
• Type of Device: FILLER, BONE
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 11059144
• MDR Text Key: 223444985
• Report Number: 3008812173-2020-00023
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 00889024205376
• UDI-Public: (01)00889024205376
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2023
• Device Model Number: N/A
• Device Catalogue Number: 514.503
• Device Lot Number: KC06746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27 YR