MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER UNI ART SURF FIXED BRG; PROSTHESIS, KNEE

Model Number N/A

Device Problems Unstable (1667); Naturally Worn (2988)

Patient Problems Synovitis (2094); Osteolysis (2377)

Event Date 12/04/2017

Event Type  Injury  

Manufacturer Narrative

Cmp-(b)(4).Concomitant medical products: unknown zuk femoral component, catalog #: unknown, lot #: unknown.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-00683, 0001822565-2018-01984.Device not returned by the patient.

Event Description

It was reported that the patient was revised to address instability and a fractured femoral component.It was noted that the femoral component was not bonded to the bone, likely causing the fracture.It was further reported the patient had an arthroscopic procedure approximately three and a half years post-implantation due to unknown reasons.Operative reports further note that the patient's gait had mild antalgic favoring of the left knee, varus collapse, and pseudolaxity of the mcl approximately five days prior to the revision procedure.During the revision procedure, the surgeon noted the polyethylene showed severe wear.Osteolysis and synovitis were also present which was the source of the femoral component loosening.All components were removed and replaced with a competitor total knee.

Manufacturer Narrative

Cmp-(b)(4).This report is being submitted to relay additional information.The following sections were updated: reported event has been confirmed by review of actual device received.Device history record (dhr) was reviewed for lot 62031428 (femoral cast) with the following deviations: 1 part was scrapped at operation 130, 2 parts were scrapped at operation 180, and 1 part was scrapped at operation 190.However, these anomalies would not have caused or contributed to the reported event as the affected units were scrapped.The investigation identified the loosening and component fracture were subsequent to the noted osteolysis; however, a definitive root cause of the osteolysis 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: ZIMMER UNI ART SURF FIXED BRG
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7395515
• MDR Text Key: 104277761
• Report Number: 0001822565-2018-01984
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2015
• Device Model Number: N/A
• Device Catalogue Number: 00584202610
• Device Lot Number: 60731548
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2007
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 132