MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PARTIAL FEMUR CEMENTED SIZE 4 RIGHT MEDIAL; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Wound Dehiscence (1154); Abscess (1690)

Event Date 05/23/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Age or dob: (b)(6).Concomitant medical products: 42558000402, partial femur cemented, lot # 6353289.42538000502, partial tibia cemented, lot # 63881381.42528200508, partial articular surface, lot # 63583930.Multiple mdr reports were filed for this event, please see associated reports: 3007963827 - 2019 - 00294, 0001822565 - 2019 - 04428.

Event Description

It was reported that approximately 6 weeks post implantation, the patient was treated for wound dehiscence and stitch abscess.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Event occurred in the (b)(6).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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were update/corrected updated: b4, b5, g4, g7, h2, h3, h6.The reported event was able to be confirmed by review of the provided clinic notes.Office notes state that patient experienced a small amount of weeping from the surgical wound and a stitch abscess approximately 6 weeks post implantation.Patient was treated with antibiotics and infection resolved within 1 week.Review of the device history records identified no deviations or anomalies during manufacturing.The root cause for the reported issue is related to the procedure and not abnormal.There is no failure detected within the device.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: PARTIAL FEMUR CEMENTED SIZE 4 RIGHT MEDIAL
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9192382
• MDR Text Key: 162442861
• Report Number: 0001822565-2019-04427
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00880304808553
• UDI-Public: (01)00880304808553
• Combination Product (y/n): N
• PMA/PMN Number: K161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42558000402
• Device Lot Number: 63532896
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 109