MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JUGGERKNOT 2.9 W/ TAPERED NDLS; FASTENER, FIXATION

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.Two anchor lot numbers were reported in conjunction with this event.It is unknown after follow-up attempts which device is related to this event.The information for the second anchor lot is as follows: lot number: 564680 expiration date: dec 28, 2022 unique identifier (udi) number: (b)(4).Device manufacture date: dec 19, 2017.Explant occurred on an unknown date in (b)(6) 2019 concomitant medical devices: item number: 800-1003a, item name: gps iii single kit, lot number: 801845; item number: 909857, item name: ziptight ankle system, lot number: 390180.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent revision approximately 5 months post-implantation due to infection, swelling, and wound complications.An anchor component was removed.Attempts have been made and no additional information is available at this time.

Event Description

Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

Manufacturer Narrative

Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, therefore implanted products are not identified as the source or contributing to the reported infection.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.

• Brand Name: JUGGERKNOT 2.9 W/ TAPERED NDLS
• Type of Device: FASTENER, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10480054
• MDR Text Key: 205264415
• Report Number: 0001825034-2020-03390
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00880304548031
• UDI-Public: (01)00880304548031
• Combination Product (y/n): N
• PMA/PMN Number: K150768
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2022
• Device Model Number: N/A
• Device Catalogue Number: 110005096
• Device Lot Number: 433670
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 113