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

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - medical product: articular surface medial congruent (mc) left 10 mm height use with tibia sizes c-d/cr femur sizes 4-5 catalog # 42512100310 lot # 65328898.Femur trabecular metal cruciate retaining (cr) narrow porous catalog # 42502205801 lot # 65258456.H3: customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported patient is experiencing tibial loosening eight months post implantation.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x-rays provided.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.X-ray review indicates there is potential early loosening, mild radiolucency, and mild osteopenia.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
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
• Common Device Name: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16913305
• Report Number: 0001822565-2023-01250
• Device Sequence Number: 6356180
• Product Code: MBH
• UDI-Device Identifier: 00889024510517
• UDI-Public: (01)00889024510517(10)310110(17)64871945
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K173417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2023

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: 42530006401
• Device Lot Number: 64871945
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2023
• Supplement Date Received by Manufacturer: 05/15/2023; 06/08/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 05/17/2023; 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female