MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN TIBIA COMPONENT; PROSTHESIS, KNEE

Model Number N/A

Device Problems Vibration (1674); Appropriate Term/Code Not Available (3191); Noise, Audible (3273)

Patient Problems Pain (1994); Swelling (2091); Limited Mobility Of The Implanted Joint (2671); Alteration In Body Temperature (2682)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the products remain implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: femoral item # unknown lot # unknown, bearing item # unknown lot # unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-02862, 0001822565-2019-02864.

Event Description

It was reported that patient underwent left total knee arthroplasty and subsequently has been experiencing pain, limited extension, swelling, vibrates, makes noise, grinding, warm to the touch.Three months after the initial procedure the patient underwent mua however patient continues to have the same issues.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h3, h6, h10.Reported event was unable to be confirmed due to limited information received from the customer.No product was returned; visual and dimensional evaluations could not be performed.Medical records were not provided.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot be determined.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: UNKNOWN TIBIA COMPONENT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8767851
• MDR Text Key: 150280524
• Report Number: 0001822565-2019-02863
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN TIBIAL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/20/2019
• Initial Date FDA Received: 07/08/2019
• Supplement Dates Manufacturer Received: 01/06/2020
• Supplement Dates FDA Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention
• Patient Weight: 85