MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL DISTAL AUGMENT CEMENTED SIZE 7, 7+ 5 MM THICKNESS; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-00313, 0001822565-2024-00314, 0001822565-2024-00315, 0001822565-2024-00316, 0001822565-2024-00317, 0001822565-2024-00318, 0001822565-2024-00319, 0001822565-2024-00320, 0001822565-2024-00321, and 0001822565-2024-00323.D10 medical devices: tibial central cone size large catalog#: 42545000513 lot#: 64987481.Stem extension tapered cemented 14 mm diameter +75 mm length catalog#: 42560007514 lot#: 66165938.Tibia fixed cemented right size e catalog#: 42542007102 lot#: 66165640.Stem extension tapered cemented 14 mm diameter +75 mm length catalog#: 42560007514 lot#: 66165938.Tibial augment cemented half block right lateral size ef 5 mm thickness catalog#: 42555805205 lot#: 65834643.Tibial augment cemented half block right medial size ef 5 mm thickness catalog#: 42555805405 lot#: 65969667.Femur cemented plus right size 7+ catalog#: 42504606212 lot#: 65667293.Femoral central cone size large catalog#: 42545001013 lot#: 64910592.Femoral distal augment cemented size 7, 7+ 10 mm thickness catalog#: 42556606210 lot#: 65263598.Articular surface fixed bearing (cck) right 18 mm catalog#: 42522800718 lot#: 64639053.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that patient underwent a right knee revision approximately seven weeks post-implantation due to infection.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Updated: b4, g3, g6, h2, h3, h6, and h10.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, implanted products are not identified as the source or contributing to the reported infection.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: FEMORAL DISTAL AUGMENT CEMENTED SIZE 7, 7+ 5 MM THICKNESS
• 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: 18617524
• Report Number: 0001822565-2024-00322
• Device Sequence Number: 7508979
• Product Code: JWH
• UDI-Device Identifier: 00889024556737
• UDI-Public: (01)00889024556737(17)330513(10)65943112
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2024

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: 42556606205
• Device Lot Number: 65943112
• 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: 01/03/2024
• Supplement Date Received by Manufacturer: 03/14/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2023
• 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: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male