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

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-05607 and 0001825034-2019-05787.Concomitant medical products: unknown persona partial knee femoral, catalog#: ni, lot#: ni, partial articular surface left medial size f 11 mm thickness, catalog#: 42518200611, lot#: 64157510.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.

Event Description

It was reported that during a knee procedure, the tibial insert would not seat on the tibial tray.The procedure was completed using another tibial insert.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.The compressed feature of the mating implant indicates that the device was not properly inserted.The root cause is attributed to use error.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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 PERSONA PARTIAL TIBIAL TRAY
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9532274
• MDR Text Key: 194370158
• Report Number: 0001825034-2019-05787
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN PARTIAL TIBIAL TRY
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 03/17/2020
• Supplement Dates FDA Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 82 YR