MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE G; PROSTHESIS, KNEE

Model Number N/A

Device Problem Migration (4003)

Patient Problem No Information (3190)

Event Date 02/10/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: articular surface medial congruent (mc) left 10 mm height use with tibia sizes g-h/cr femur size 12 catalog#: 42512101010, lot#: 63179244.Femur trabecular metal cruciate retaining (cr) standard porous, catalog#: 42502807401, lot#: 64116364.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent a left total knee arthroplasty.Subsequently, approximately thirteen (13) months later, the patient was revised due to subsidence.No additional information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Updated: b4, g4, g7, h2, h3, h6, and h10.Visual evaluation of the returned implant shows signs of being implanted.A small quantity of bone cement adhered to the inferior-medial side.Dimensions were conforming to the print.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause 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: NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE G
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9774208
• MDR Text Key: 189465885
• Report Number: 0001822565-2020-00758
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024246553
• UDI-Public: (01)00889024246553(17)280331(10)63927610
• Combination Product (y/n): N
• PMA/PMN Number: K173417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 06/09/2020

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
• Device Model Number: N/A
• Device Catalogue Number: 42530007901
• Device Lot Number: 63927610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/10/2020
• Initial Date FDA Received: 03/02/2020
• Supplement Dates Manufacturer Received: 05/15/2020
• Supplement Dates FDA Received: 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention