MAUDE Adverse Event Report: ZIMMER BIOMET, INC. KNE-UNKNOWN-TIBIAL-; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Pain (1994); Swelling (2091); Reaction (2414)

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.Additional associated products and mdrs: kne-unknown-femoral- mdr: 0001822565-2021-00253.

Event Description

It was reported that patient underwent left total knee arthroplasty.Subsequently, approximately three years and two months post procedure, the patient experiences pain/discomfort, swelling, tightness and found she has metal sensitivity to nickel.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Medical records were not provided.This complaint cannot be confirmed.A definitive root cause cannot be determined with the information provided no corrective actions, preventive actions, or field actions resulted after investigation of this event.Additional associated products and mdrs knee-unknown-bearing-unknown mdr: 0001822565-2021-00433.

Event Description

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

• Brand Name: KNE-UNKNOWN-TIBIAL-
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11244204
• MDR Text Key: 229138108
• Report Number: 0001822565-2021-00254
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• 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: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other