MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN NEXGEN FEMORAL COMPONENT SIZE G; PROSTHESIS, KNEE

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

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

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: unknown nexgen tibial tray size 8: catalog#ni, lot#ni; unknown nexgen articular surface 10mm: catalog#ni, lot#ni; unknown patella component size 41: catalog#ni, lot#ni; unknown bone cement: catalog#ni, lot#ni.Multiple mdr reports have been filed for this event.Please see associated reports: 0001822565-2022-03560; 0001822565-2022-03562; 0001822565-2022-03563.The root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device, a review of the device history records was not performed.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.As was the case here, larger hematomas may need to be surgically evacuated (irrigation and debridement) in order to resolve.As timeframes of onset differ due to individual contributing factors, a specific timeframe of expected occurrence cannot be established.As such, the root cause of the reported event was determined to be unrelated to the implanted device.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 via a clinical study that a patient underwent an initial right total knee arthroplasty.Subsequently, within weeks post-implantation, the patient underwent an irrigation and debridement procedure for a hematoma.The exact event date is unknown.Due diligence is complete as multiple attempts have been made.It was reported that no further information is available.

• Brand Name: UNKNOWN NEXGEN FEMORAL COMPONENT SIZE G
• Type of Device: PROSTHESIS, KNEE
• 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: 16019042
• MDR Text Key: 305870874
• Report Number: 0001822565-2022-03561
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2022
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 117 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White