MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL AUGMENT CEMENTED HALF BLOCK; 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	07/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Two device ids were provided by the reporter; of these, only one (1) was reported for revision procedure occurred due to infection and loosening.It is unknown which exact device encountered this issue, it is one of the following: tibial augment cemented half block item#: 42555805305, lot#: 64508912.Manufacture date: sep 30, 2019.Sterile expiry date: sep 30, 2029.Udi: (b)(4).510k: k191625, pro code: mbh.Or tibial augment cemented half block item#: 42555805305, lot#: 64508912.Manufacture date: sep 30, 2019.Sterile expiry date: sep 30, 2029.Udi: (b)(4).510k: k191625, pro code: mbh.Medical products : femur cemented standard catalog # 42504606201 lot # 64683452.Tibia fixed cemented stem extension catalog # 42542007101 lot # 64599628.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 1.Articular surface fixed bearing constrained condylar knee (cck) catalog # 42512800718 lot # 64435986.Multiple mdr reports were filled for this event: 0001822565-2022-00802, 0001822565-2022-00805, 0001822565-2022-01530, 0001822565-2022-01531.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.
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.

• Brand Name: TIBIAL AUGMENT CEMENTED HALF BLOCK
• 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: 15240145
• Report Number: 0001822565-2022-01532
• Device Sequence Number: 11986835
• Product Code: MBH
• UDI-Device Identifier: 00889024557185
• UDI-Public: (01)00889024557185(17)290930(10)64508912
• 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
• Report Date (Section B): 08/17/2022

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: 42555805305
• Device Lot Number: 64508912
• 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: 08/09/2022
• Initial Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2019
• 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