MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 6.0 MM DIAMETER CANCELLOUS SCREW FIXED ANGLE 3.5 MM HEX HEAD; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 47248405060

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Sepsis (2067); Impaired Healing (2378)

Event Type  Injury  

Event Description

It was reported via a clinical study that a patient underwent a bone fixation procedure of the right femur.On an unknown time frame post-implantation, the patient developed a traumatic right femoral hematoma with a wound healing disorder.Blood cultures tested positive for e.Coli in sepsis and a smear also tested positive for e.Coli.Subsequently, the patient underwent medical intervention including a jet lavage procedure to clear the hematoma and wound.Due diligence is complete as multiple attempts have been made; however no further information is available and the product remains implanted.

Manufacturer Narrative

(b)(4).Event occurred in 2015 though exact date is unknown.Implantation occurred in 2015 though exact date is unknown.Concomitant medical products: retrograde femoral nail - purple 10 mm diameter 36 cm length: catalog#47249436010, lot#61295569; 6.0 mm diameter cancellous screw - black fixed angle 3.5 mm hex head: catalog#47248405060, lot#61143263; 6.0 mm diameter cancellous screw - black fixed angle 3.5 mm hex head: catalog#47248405560, lot#61222158; 6.0 mm diameter cancellous screw - black fixed angle 3.5 mm hex head: catalog#47248406560, lot#61374598; 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head: catalog#47248403250, lot#61812273; 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head: catalog#47248403750, lot#61711476.Foreign source: germany.Multiple mdr reports have been filed for this event.Please see associated reports: 0001822565-2022-03012; 0001822565-2022-03013; 0001822565-2022-03014; 0001822565-2022-03015; 0001822565-2022-03017; 0001822565-2022-03018.Customer has indicated that the product will not be returned to zimmer biomet for evaluation, as it remains implanted.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10: medical product: retrograde femoral nail - purple 10 mm diameter 36 cm length: catalog#: 47249436010, lot#: 61295569; 6.0 mm diameter cancellous screw - black fixed angle 3.5 mm hex head: catalog#: 47248405060, lot#: 61143263; 6.0 mm diameter cancellous screw - black fixed angle 3.5 mm hex head: catalog#: 47248405560, lot#: 61222158; 6.0 mm diameter cancellous screw - black fixed angle 3.5 mm hex head: catalog#: 47248406560, lot#: 61374592; 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head: catalog#: 47248403250, lot#: 61812273; 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head: catalog#: 47248403750, lot#: 61711476.The reported infection/sepsis that developed was identified as positive for e.Coli bacteria, which was obtained via culture of the hematoma.A hematoma is a mass of clotted blood that forms in a tissue, organ, or body space.A hematoma can be associated with pain, swelling, ecchymosis, serosanguinous or bloody drainage after a recent surgical procedure or trauma and can predispose the patient to infection.The development of a postoperative hematoma can be correlated with the surgical procedure and perioperative anticoagulation therapy prescribed to prevent thrombus formation.Most hematomas resolve on their own, without surgical intervention, while some do not.Larger hematomas may need to be surgically evacuated in order to resolve.As timeframes of onset differ due to individual contributing factors, a specific timeframe of expected occurrence cannot be established.Investigation results concluded that the reported event was due to non-device related factors.Device history record was reviewed and no discrepancies related to the reported event were found.Sterile certifications were also reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.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, 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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information at time of this report.

• Brand Name: 6.0 MM DIAMETER CANCELLOUS SCREW FIXED ANGLE 3.5 MM HEX HEAD
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 15650059
• MDR Text Key: 302174942
• Report Number: 0001822565-2022-03016
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K083497
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 47248405060
• Device Lot Number: 61236378
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female