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

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: 42522000510, articular surface, lot # 64295096, 42502806402, femoral component, lot # 64238042, 42540200035, patella, lot # 64021230.Report source: (b)(6).
Event or Problem Description
It was reported that approximately 7 months post implantation, the patient was revised due to subsidence of the tibial component.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Photographs of the removed implants showed some bone growth on the base porous side, confirming the revision.X-ray review by a hcp confirmed that there was medial tray subsidence with abnormal lucencies along the tibial implant with loosening.Bone quality was osteopenic.Review of the device history records did not identify any deviations or anomalies during manufacturing.A definitive root cause could not 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 or Problem Description
No further event information available at the time of this report.

• Brand Name: NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING RIGHT SIZE F
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9886243
• Report Number: 0001822565-2020-01128
• Device Sequence Number: 2897221
• Product Code: MBH
• UDI-Device Identifier: 00889024510586
• UDI-Public: (01)00889024510586
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42530007502
• Device Lot Number: 64055801
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/13/2020
• Supplement Date Received by Manufacturer: 04/24/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 05/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 60