MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMUR CEMENTED STANDARD LEFT SIZE 5; PROSTHEIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	09/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a knee procedure and approximately 1 year later, was revised due to instability.The patient was revised to a new system and the surgeon noted that the implants were well fixed.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 42522400418 - articular surface fixed bearing posterior stabilized (ps) right 18 mm heigh - 64667021.42542006402 - tibia fixed cemented right size c stem extension use required - 64960938.42556605805 - femoral distal augment cemented size 5, 5+ 5 mm thickness - 64988990.42556605810 - femoral distal augment cemented size 5, 5+ 10 mm thickness - 64863054.42560113512 - stem extension straight splined uncemented 12 mm diameter +135 mm length - 64963305.42555803405 - tibial augment cemented half block right medial size cd 5 mm thickness - 65042379.42555803205 - tibial augment cemented half block right lateral size cd 5 mm thickness - 65314944.42560313512 - stem extension 3mm offset splined uncemented 12 mm diameter +135 mm length - 65042683.66022663 - palacos r + g (1x40) - 62501128.66022663 - palacos r + g (1x40) - 62501128.66022663 - palacos r + g (1x40) - 62221123.G2 : foreign country : australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2023-00286.
Additional Manufacturer Narrative
Upon receipt of additional information, it has been determined that there were no allegations against this zimmer biomet device as the patient underwent a right knee revision surgery, not a left knee revision surgery.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: FEMUR CEMENTED STANDARD LEFT SIZE 5
• Common Device Name: PROSTHEIS, 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: 17942142
• Report Number: 0001822565-2023-02850
• Device Sequence Number: 6773569
• Product Code: JWH
• UDI-Device Identifier: 00889024562530
• UDI-Public: (01)00889024562530(17)310329(10)64998914
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 01/17/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42504605801
• Device Lot Number: 64998914
• 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: 09/26/2023
• Supplement Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female