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

Model Number	N/A
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	03/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).00599402212 - articular surface with locking screw 'size striped purple/c d 12 mm height' - 61842102.00599003420*op1000 - prc agmt block dist sz d 10mm - 63880048.00599003420*op1000 - prc agmt block dist sz d 10mm - 63162325.00598801013 - stem extension straight 13mm dia x 100mm length(combined length 145mm) - 63959225.00598002701 - stemmed tibial component precoat size 1 for cemented use only use of this tibial component with lcck articulating surfaces requires using a stem exten - 62785418.00598800126 - tibial half block augment precoat size 1 5 mm thickness - 63917559.00598802011 - stem extension offset 11mm dia x 100mm length(combined length 145mm) - 63845553.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: 0001822565-2022-00972.
Event or Problem Description
It was reported that the patient underwent a right knee surgery and approximately 5 years later, experienced sudden onset of pain, clicking, and swelling of the right knee.Subsequently, the patient underwent a revision as the screw from the lcck poly had backed all the way out of the poly and was in the back of the knee.All of the threads were noted to be worn.Only the poly insert was exchanged.Attempts have been made and no further information has been provided.
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.Upon receipt of additional information, it has been determined that this zimmer biomet device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

• Brand Name: FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE D RIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14014145
• Report Number: 0001822565-2022-00973
• Device Sequence Number: 6288501
• Product Code: JWH
• UDI-Device Identifier: 00889024224797
• UDI-Public: (01)00889024224797(17)270331(10)63431965
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 07/08/2022

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 Model Number: N/A
• Device Catalogue Number: 00599401492
• Device Lot Number: 63431965
• 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: 03/21/2022
• Supplement Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2017
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Female
• Patient Weight: 77 KG