MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NON-MODULAR CEMENTED TIBIAL COMPONENT; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical product: trabecular metal tibial cone catalog # 00545001331 lot # 63166998.Headed screw catalog # 00579104100 lot # 63201402.Headless screw catalog # 00579104200 lot # 62565597.Headless screw catalog # 00579104200 lot # 62924025.Headless screw catalog # 00579104200 lot # 63024958.Headless screw catalog # 00579104200 lot # 63168756.Femoral component catalog # 00588001402 lot # 62730118.Articular surface with hinge post extension catalog # 00588004014 lot # 62888136.Stem extension catalog # 00598801018 lot # 63048016.Femoral augment catalog # 00599003421 lot # 62514090.Femoral augment catalog # 00599003421 lot # 62939603.Australia.Reporter had indicated that product will not be returned.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Other.
Event or Problem Description
It was reported patient underwent a revision procedure seven years post implantation due to tibial loosening.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 for deviations and anomalies.A definitive root cause cannot be determined.X-ray review indicates there is abnormal alignment of the tibial component and mild genu varus, mild periprosthetic lucencies surrounding the tibial screws, signs of loosening.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: NON-MODULAR CEMENTED TIBIAL COMPONENT
• 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: 16945142
• Report Number: 0001822565-2023-01336
• Device Sequence Number: 15042031
• Product Code: JWH
• UDI-Device Identifier: 00889024199002
• UDI-Public: (01)00889024199002(17)200831(10)63101447
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2023

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 Expiration Date: 08/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 00588000302
• Device Lot Number: 63101447
• 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: 04/26/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 81 KG