MAUDE Adverse Event Report: ZIMMER BIOMET, INC. KNE-NEXGEN-UNK-FEMORAL; PROSTHESIS, KNEE

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Ambulation Difficulties (2544); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 11/17/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer's legal representation has not made any information regarding the event or product location available to zimmer biomet.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs: kne-nexgen-unk-tibial, mdr: 0001822565-2023-01353.Kne-nexgen-unk-bearing, mdr: 0001822565-2023-01354.

Event Description

It was reported by patient's legal counsel that the patient underwent a knee revision procedure on an unknown date due to unknown reasons.No additional information available at this time.

Event Description

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

Manufacturer Narrative

His follow-up report is being submitted to relay additional information.Componenet code- suggested code- mechanical femur.  no product or photograph were returned ; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Insufficient information provided to perform a compatibility check.Complaint history review cannot be performed without product identification.Medical records were not provided this complaint cannot be confirmed.Root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.  the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported by legal that a right initial unicompartmental knee arthroplasty was performed.Subsequently, approximatley six years and fout months post procedure the patient was revised due to pain, noise, difficulty ambulating, and dislocation.During the revision it was noted the polyethylene was fractured.Tibia and femur remained implanted.Polyethylene exchanged without complications.

• Brand Name: KNE-NEXGEN-UNK-FEMORAL
• 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: 16953221
• MDR Text Key: 315468998
• Report Number: 0001822565-2023-01352
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2023
• 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): Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose