MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RIGHT SIZE D CEMENTED OPTION FEMORAL COMPONENT; PROSTHESIS, 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)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial knee procedure on an unknown date.Subsequently, the patient has undergone multiple revisions and is currently being considered for another revision due to ongoing instability.A revision surgery has not been scheduled yet.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 00599402223 - 23mm height size c,d with locking screw striped purple articular surface use with femoral c,d / screw enclosed do not discard - 63649367.00598801013 - 13mm diameter 100mm length straight stem extension combined length 145mm - 63187582.00599003410 - prc agmt block dist sz d 5mm - 62266190.00599003410 - prc agmt block dist sz d 5mm - 62963054.00598002701 - stemmed tibial component precoat size 1 for cemented use only use of this tibial component with lcck articulating surfaces requires using a stem exten - 63341475 00598801011 - 11mm diameter 100mm length straight stem extension combined length 145mm - 63333183.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.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: 0001822565-2023-03003.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6 : suggested code : mechanical (g04) - femur.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: possible loosening of the tibial component at the bone cement interface and patellar baja which may relate to patient's quadriceps tear.A definitive root cause cannot 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 available at the time of this report.

• Brand Name: RIGHT SIZE D CEMENTED OPTION FEMORAL 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: 18029072
• Report Number: 0001822565-2023-03004
• Device Sequence Number: 6961863
• Product Code: JWH
• UDI-Device Identifier: 00889024224797
• UDI-Public: (01)00889024224797(17)260630(10)63398784
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2024

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 Expiration Date: 06/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 00599401492
• Device Lot Number: 63398784
• 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: 10/10/2023
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2016
• 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: Other
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 90 KG