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

Model Number N/A

Device Problem Migration (4003)

Patient Problems Pain (1994); No Information (3190)

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.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 is experiencing the implant shift approximately 2 years post-implantation.No intervention has been reported at this time.Attempts have been made and no additional information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: a1, a5, b4, b5, b7, d4, e1, e2, e3, g4, h2, h4, h6 corrected: a2, h4 d4: previously it was stated that two product identifications were provided for this event and it could not be determined which device was involved in the event.Additional information has been received and d4 reflects the correct product identification.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported patient underwent an initial left tendon repair due to a history of falls and instability.Approximately three weeks post-op, the patient fell in her bathtub and scraped her incision causing wound dehiscence at the surgical site.The wound was debrided at each subsequent follow up visit.At three months postop, the patient presented to the er with pain and swelling in the ankle.The wound cultures obtained were positive for bacterial growth, and the patient was admitted for cellulitis treatment.Patient underwent a surgical wound debridement and irrigation with explantation of sutures.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records noting orthotic shoes recommended due to continued ankle instability.Edema is seen in the soft tissues surrounding the left distal fibular/lateral malleolus.Disruption of the anterior talofibular ligament is still suggested.Minimal marrow edema is seen in the medial malleolus articular surface.Pain was noted, and patient requested disability paperwork, narcotics prescribed.Dhr was reviewed and no discrepancies were found.The root cause is unable to be determined.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 additional event information to report at this time.

• 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: 10479633
• MDR Text Key: 205266770
• Report Number: 0001825034-2020-03383
• 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,health p
• Type of Report: Initial,Followup,Followup
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2022
• Device Model Number: N/A
• Device Catalogue Number: 110005096
• Device Lot Number: 564680
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 09/01/2020
• Supplement Dates Manufacturer Received: 10/09/2020; 12/28/2020
• Supplement Dates FDA Received: 10/29/2020; 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 113