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

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Joint Swelling (2356)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: unknown zimmer femoral, item # unknown, lot # unknown.Unknown zimmer bearing, item # unknown, lot # unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation due to the device still implanted.The investigation is in process.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: 0001822565-2017-04017 and 0001822565-2017-04019.

Event Description

It was reported following a knee arthroplasty, the patient is experiencing pain and extreme swelling.The patient has been using ice to provide relief on the pain and swelling.Attempts have been made and additional information on the reported event is unavailable at this time.No additional patient consequences were reported.

Manufacturer Narrative

(b)(4).The reported event could not be confirmed based on limited information received.No products were returned; therefore, the visual and dimensional inspections were not performed.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.The compatibility check and complaint history search were not performed.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.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.

• Brand Name: UNKNOWN ZIMMER TIBIAL TRAY
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6638116
• MDR Text Key: 77497749
• Report Number: 0001822565-2017-04018
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2017
• 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): Required Intervention
• Patient Weight: 82