MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ARTICULAR SURFACE; PROSTHESIS, KNEE

Model Number N/A

Device Problem Noise, Audible (3273)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Type  Injury  

Event Description

It was reported that the patient underwent an initial right tka approximately 13 years ago.Subsequently, the patient started experiencing pain approximately 2 years ago.The patient's pain is from her knee to her ankle.Patient is using a wheel chair and hears a horrible noise in the knee when walking.The patient has been evaluated by several doctors for the issues and has had imaging performed and was told that the knee looked fine.One physician did notice the noise and wanted to do an exploratory surgery, however, the patient declined.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Implant date: 2009.Unknown - unknown femoral component - unknown.Unknown - unknown tibial component - unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-02428 and 0001822565-2022-02429.

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.The device history record was unable to be performed as the lot number of the device involved in the event is unknown.Medical records were not 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 report 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 ARTICULAR SURFACE
• 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: 15265253
• MDR Text Key: 298299179
• Report Number: 0001822565-2022-02427
• Device Sequence Number: 1
• Product Code: JWH
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/02/2022
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 100 KG