MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIA FIXED CEMENTED STEM EXTENSION; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical products: unknown femoral component catalog # unknown lot # unknown; unknown articular surface catalog # unknown lot # unknown.Customer has indicated that the product will not be returned because product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001822565-2022-00802, 0001822565-2022-00804.Product location unknown.
Event or Problem Description
It was reported patient underwent a revision procedure on unknown date due to unknown reason.Attempts to obtain additional information have been made; however, no more is available at this time.
Additional Manufacturer Narrative
Upon receipt of additional information, it was determined that the initial report was submitted in error and should be voided.It is now verified that implanted products are not identified as the source or contributing to the reported infection.
Event or Problem Description
Upon receipt of additional information, it was determined that the initial report was submitted in error and should be voided.It is now verified that 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.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.
Event or Problem Description
It was reported patient underwent a revision procedure two months post implantation due to infection and loosening.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.H6: health effect - clinical code - no clinical signs, symptoms or conditions and device code(s) insufficient information is n/a which was reported on initial report.It was previously reported on mfr#: 0001822565-2022-00805-1 that this device was not related to the event.However, upon receipt of additional information, it is now verified that this device is related to the event.D10 ¿ medical products femur cemented standard catalog#: 42504606201, lot#: 64683452.Femoral distal augment cemented catalog#: 42556606210, lot#: 64508941 qty 2.Tibial augment cemented half block catalog#: 42555805105, lot#: 64453278 qty 2.Tibial augment cemented half block catalog#: 42555805305, lot#: 64508912 qty 2.Articular surface fixed bearing constrained condylar knee (cck) catalog#: 42512800718, lot#: 64435986.Multiple mdr reports were filled for this event: 0001822565-2022-01530, 0001822565-2022-01531, 0001822565-2022-01532.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.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: TIBIA FIXED CEMENTED STEM EXTENSION
• 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: 13869734
• Report Number: 0001822565-2022-00805
• Device Sequence Number: 4665612
• Product Code: JWH
• UDI-Device Identifier: 00889024562790
• UDI-Public: (01)00889024562790(17)300228(10)64599628
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/14/2022

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: 42542007101
• Device Lot Number: 64599628
• 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: 03/02/2022
• Supplement Date Received by Manufacturer: 03/30/2022; 08/09/2022; 08/25/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 04/27/2022; 08/17/2022; 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 66 KG