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

Model Number N/A

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Date 12/16/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: articular surface medial congruent (mc) left 10 mm height use with tibia sizes e-f/cr femur sizes 6-7 catalog#: 42512100710 lot#: 63175219, all poly patella standard size 38 mm diameter 9.5 mm thickness cemented catalog#: 00597206538 lot#: 64209115, femur cemented cruciate retaining (cr) standard left size 9 catalog#: 42502606601 lot#: 63992838.Customer has indicated that the product will not be returned to zimmer biomet for investigation, the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent a revision procedure approximately eight months post-implantation due to a 0.8 degree tibial subsidence.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Medical records were provided and reviewed by a health care professional.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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 E
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10173642
• MDR Text Key: 195736184
• Report Number: 0001822565-2020-02194
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024248515
• UDI-Public: (01)00889024248515
• Combination Product (y/n): N
• PMA/PMN Number: K173417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

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: 42530007101
• Device Lot Number: 62620484
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 06/19/2020
• Supplement Dates Manufacturer Received: 07/20/2020
• Supplement Dates FDA Received: 07/22/2020
• 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
• Patient Weight: 119