MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN PERSONA TIBIAL TRAY; PROSTHESIS, KNEE

Device Problems Material Erosion (1214); No Apparent Adverse Event (3189)

Patient Problems Synovitis (2094); Metal Related Pathology (4530); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

It was reported that a patient underwent an initial knee procedure on an unknown date.Subsequently, the patient developed persistent synovitis and displayed high synovial levels of chrome, cobalt, and nickel.Due diligence is in progress for this event; further information regarding subsequent medical intervention or patient outcome is currently unknown.

Manufacturer Narrative

(b)(4).D10: medical products: unknown persona femoral component: catalog#ni, lot#ni; unknown persona articular surface: catalog#ni, lot#ni.G2: foreign: italy.Multiple mdr reports have been filed for this event.Please see associated report: 0001822565-2023-02917.The product will not be returned to zimmer biomet for investigation, as the product location is currently unknown.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.H3 other text : see h10 narrative.

Event Description

It was originally reported that a patient was experiencing persistent synovitis and displaying high synovial levels of chrome, cobalt and nickel following a total knee arthroplasty.Further correspondence clarified that the surgeon was intending to submit an inquiry regarding expected synovial levels and was not making allegations against the reported device.The patient is not currently experiencing synovitis, elevated metal ions, or further impact as a result of the implanted device.The initial incident report was forwarded in error.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Upon receipt of additional information, it was determined that this initial incident report was forwarded in error.The patient is not currently experiencing any impact as a result of the implanted device.Additional correspondence indicated that the surgeon was submitting an inquiry regarding expected synovial levels and is not currently making any allegations against the device.As there is no allegation against the product, and the surgeon was only requesting information, investigation results concluded that there was no issue with the product.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.

• Brand Name: UNKNOWN PERSONA TIBIAL TRAY
• 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: 17974613
• MDR Text Key: 326127894
• Report Number: 0001822565-2023-02918
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/09/2023
• Initial Date FDA Received: 10/20/2023
• Supplement Dates Manufacturer Received: 11/17/2023
• Supplement Dates FDA Received: 12/11/2023
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose