MAUDE Adverse Event Report: ZIMMER BIOMET, INC. XTRAFIX EXTERNAL FIXATION SYSTEM; PROSTHESIS TRAUMA

Model Number N/A

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported that a patient underwent placement of a xtrafix device, at an unknown site.Subsequently, six days later, underwent a readjustment due to loss of position.No additional information is available.

Manufacturer Narrative

(b)(4).Report source: uk.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

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

Manufacturer Narrative

(b)(4).Updated: b4, b5, g3, h1, h2, h6, h10.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Procedural-related complications are influenced by the type of surgery, patient's pre-existing comorbidities, and perioperative management.During a procedure with general anesthesia, the brain is exposed to a myriad of drugs that alter the chemical balance in the sleep/arousal pathway. this imbalance may cause delirium, a neurocognitive syndrome caused by reversible neuronal disruption due to an underlying systemic perturbation. post-operative delirium can occur from anywhere between 10 minutes after anesthesia up until discharge from the hospital. it is commonly recognized as a sudden, fluctuating, and usually reversible disturbance of mental status with a degree of inattention.As the complaint indicated, a postoperative complication developed that typically requires medical intervention and contributed to the patient's inability to comply with post-operative restrictions.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

It was further reported by a retrospective study, a patient underwent placement of a xtrafix device, at an unknown site on the left extremity.The patient suffered post-operative hyperactive delirium and could not comply with instructions for elevation and non-weight bearing status.Subsequently, loss reduction and underwent an adjustment.The patient¿s condition stabilized and underwent definitive fixation and the event was considered resolved.

• Brand Name: XTRAFIX EXTERNAL FIXATION SYSTEM
• Type of Device: PROSTHESIS TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15103830
• MDR Text Key: 296597300
• Report Number: 0001822565-2022-02217
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention