MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE C LEFT; PROSTHESIS, KNEE

Model Number	5880-13-01
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date of event : exact onset date is unknown.Concomitant medical products : ng rot.Hinge knee tib plt sz2; catalog#00588000200, lot#64676971; stem implant 12mmdx145mm: catalog#00598801012, lot#65152242; prc agmt block dist sz c 5mm: catalog#00599003310, lot#63949324; art surface 14mm fem sz c: catalog#00588003014, lot#64174065; palacos mv+g 2x20: catalog#66031998, lot#97665320.Report source : foreign: germany.The product will not be returned to zimmer biomet for evaluation, as the product remains implanted.The investigation is in progress.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent an initial total knee arthroplasty.Approximately one year post-implantation, diagnostic images have revealed unusual movement when the leg is fully extended.According to the surgeon, the knee can be pushed approximately four (4) degrees into the valgus and the femoral component wobbles in the connecting notch.At this time, the product remains implanted and no further intervention has been reported.Due diligence is in progress for this event; to date no further information has been provided.
Additional Manufacturer Narrative
H6: proposed component code: mechanical (g04) - femur.Multiple mdr reports have been filed for this event.Please see associated report: 0001822565-2023-01483.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.The product remains implanted.Device history record was reviewed and no discrepancies related to the reported event were found.Radiographs were provided however were not reviewed as the provided x-rays were not same a/p view.Comparing the provided x-rays would not address the alleged malfunction as both x-rays were different view showing different angle.Additional radiographic images are not available.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information at time of this report.

• Brand Name: FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE C LEFT
• 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: 16225462
• Report Number: 0001822565-2023-00180
• Device Sequence Number: 5350945
• Product Code: JWH
• UDI-Device Identifier: 00889024199101
• UDI-Public: (01)00889024199101(17)251014(10)64695413
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173057
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/14/2025
• Device Model Number: 5880-13-01
• Device Catalogue Number: 00588001301
• Device Lot Number: 64695413
• 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: 01/13/2023
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2020
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Patient Sex: Prefer Not To Disclose