MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LEFT SIZE D CEMENTED OPTION FEMORAL COMPONENT FEMORAL; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 5 years post implantation, the patient was revised due to pain and instability.No obvious cause for instability was identified during the revision procedure.Attempts have been made and no additional information is available.
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the facility.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted g2: australia.Additional associated products & mdrs: 00598800300 size 3 precoat cemented stemmed a/p wedged tibial, lot#: 63885791, mdr: 0001822565-2023-02872.00598802012 12mm diameter 100mm length offset stem ext combined length 145mm, lot#: 63981070, mdr: 0001822565-2023-02873.00598802013 13mm diameter 100mm length offset stem ext combined length 145mm, lot#: 63941617, mdr: 0001822565-2023-02874.00599003410 prc agmt block dist sz d 5mm, lot#: 63683407, mdr: 0001822565-2023-02875.00599403012 2mm height size c,d with locking screw yellow articular surface, lot#: 63713247, mdr: 0001822565-2023-02877.
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.  h6-component code- suggested code: mechanical g4 -femur.Visual examination of the returned provided pictures identified explanted implants which were covered in blood.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: hinged left total knee arthroplasty with no hardware failure or loosening.No fracture seen.Complaint cannot be confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.

• Brand Name: LEFT SIZE D CEMENTED OPTION FEMORAL COMPONENT FEMORAL
• 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: 17943935
• Report Number: 0001822565-2023-02876
• Device Sequence Number: 20789155
• Product Code: JWH
• UDI-Device Identifier: 00889024224780
• UDI-Public: (01)00889024224780(17)271130(10)63850332
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K960279
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2024

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: 00599401491
• Device Lot Number: 63850332
• 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: Not provided
• Supplement Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2017
• 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: 145 KG